Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. For safety and dosing guidelines for ALIMTA, see complete Warnings and Precautions, Adverse Reactions, and Dosage and Administration sections in the full Prescribing Information and Patient Prescribing Information. About Verzenio® (abemaciclib) Verzenio (abemaciclib) is an inhibitor of cyclin-dependent kinases (CDK)4 & 6, which are activated by binding to D-cyclins. The most common serious adverse reactions with CYRAMZA with docetaxel were febrile neutropenia (14%), pneumonia (6%), and neutropenia (5%). Optimize blood pressure prior to initiating Retevmo. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. Increased AST occurred in 51% of patients, including Grade 3 or 4 events in 8% and increased ALT occurred in 45% of patients, including Grade 3 or 4 events in 9%. An additional safety analysis, focusing on hypersensitivity reactions in RET fusion-positive NSCLC patients previously treated with immune checkpoint inhibitors, will also be presented. Limitation of Use: ALIMTA is not indicated for the treatment of patients with squamous cell non-small cell lung cancer. The deal supplements Eli Lilly's pipeline of cancer-oriented medicines with assets from Loxo, which was incorporated in 2013 and has a number of promising treatments at various stages of development. Global Aurora-A Kinase Inhibitors Pipeline Insight Report 2021: TransThera Biosciences, Eli Lilly and Co, Takeda Oncology, Wigen Biomedicine, TT-00420. ERBITUX can cause hypomagnesemia. Advise pregnant women of the potential risk to a fetus. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Monitor for Retevmo-related adverse reactions in patients with hepatic impairment. The most frequently reported ≥5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of MONARCH 2 were neutropenia (27% vs 2%), diarrhea (13% vs <1%), leukopenia (9% vs 0%), anemia (7% vs 1%), and infections (6% vs 3%). Concomitant use of Retevmo with CYP2C8 and CYP3A substrates increase their plasma concentrations which may increase the risk of adverse reactions related to these substrates. Use of Retevmo for these indications is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 12 years and older. Retevmo may affect both tumor cells and healthy cells, which can result in side effects. The most common adverse reactions (all Grades) observed in single agent CYRAMZA-treated HCC patients at a rate of ≥10% and ≥2% higher than placebo were fatigue (36% vs 20%), peripheral edema (25% vs 14%), hypertension (25% vs 13%), abdominal pain (25% vs 16%), decreased appetite (23% vs 20%), proteinuria (20% vs 4%), nausea (19% vs 12%), ascites (18% vs 7%), headache (14% vs 5%), epistaxis (14% vs 3%), insomnia (11% vs 6%), pyrexia (10% vs 3%), vomiting (10% vs 7%), and back pain (10% vs 7%). The data include positive results from the Phase 3 monarchE study of Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) for the treatment of high risk HR+, HER2- early breast cancer. At Lilly Oncology, we are dedicated to developing and delivering innovative new medicines that will make a meaningful difference to cancer patients. CYRAMZA® Lung Cancer Data Highlights Earlier this year, the FDA approved CYRAMZA® (ramucirumab) in combination with erlotinib for the first-line treatment of people with metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations, based on results from the Phase 3 RELAY study. Please see full U.S. Prescribing Information for CYRAMZA. Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors. The most common grade 3 and 4 adverse reactions for ERBITUX in combination with radiation therapy (≥10%) versus radiation alone included: radiation dermatitis (23% vs 18%), acneiform rash (17% vs 1%), and weight loss (11% vs 7%). Diarrhea occurred in 81% of patients receiving Verzenio plus an aromatase inhibitor in MONARCH 3, 86% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and 90% of patients receiving Verzenio alone in MONARCH 1. Do not initiate Retevmo in patients with uncontrolled hypertension. The rate of gastrointestinal perforation in REGARD was 0.8% and the rate of IRR was 0.4%. With severe hepatic impairment (Child-Pugh Class C), reduce the Verzenio dosing frequency to once daily. The most frequently reported ≥5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of MONARCH 3 were neutropenia (22% vs 2%), diarrhea (9% vs 1%), leukopenia (8% vs <1%), ALT increased (7% vs 2%), and anemia (6% vs 1%). Based on animal data and its mechanism of action, ERBITUX can cause fetal harm when administered to a pregnant woman. However, the tolerability of the recommended dose is supported by safety data from additional studies of ERBITUX. Based on safety data from REACH-2, in patients with Child-Pugh A liver cirrhosis, the pooled incidence of hepatic encephalopathy and hepatorenal syndrome was higher for patients who received CYRAMZA (6%) compared to patients who received placebo (0%). No dosage adjustments are necessary in patients with mild or moderate hepatic (Child-Pugh A or B) and/or renal impairment (CLcr ≥30-89 mL/min). Both Phase 3 trials are currently enrolling patients. Ketoconazole is predicted to increase the AUC of abemaciclib by up to 16-fold. Monitor the QT interval more frequently when Retevmo is concomitantly administered with strong and moderate CYP3A inhibitors or drugs known to prolong QTc interval. Pharmaceutical giant Eli Lilly announced Monday it will acquire Loxo Oncology for around $8 billion, the latest big transaction aimed at developing and monetizing new treatments for cancer. TYVYT is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. The most frequently reported ≥5% Grade 3 or 4 adverse reactions from MONARCH 1 with Verzenio were neutropenia (24%), diarrhea (20%), fatigue (13%), infections (7%), leukopenia (6%), anemia (5%), and nausea (5%). Head and Neck Cancer ERBITUX (cetuximab) is approved: Metastatic Colorectal Cancer ERBITUX is indicated for the treatment of KRAS wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test for this use: Limitations of Use: ERBITUX is not indicated for treatment of RAS-mutant colorectal cancer or when the results of the RAS mutation tests are unknown. Monitor blood pressure every two weeks or more frequently as indicated during treatment. Laboratory abnormalities (all grades; Grade 3-4) ≥20% worsening from baseline in patients who received Retevmo in LIBRETTO-001, were AST increased (51%; 8%), ALT increased (45%; 9%), increased glucose (44%; 2.2%), decreased leukocytes (43%; 1.6%), decreased albumin (42%; 0.7%), decreased calcium (41%; 3.8%), increased creatinine (37%; 1.0%), increased alkaline phosphatase (36%; 2.3%), decreased platelets (33%; 2.7%), increased total cholesterol (31%; 0.1%), decreased sodium (27%; 7%), decreased magnesium (24%; 0.6%), increased potassium (24%; 1.2%), increased bilirubin (23%; 2.0%), and decreased glucose (22%; 0.7%). In Studies JMEN. It could not be determined whether these mucocutaneous adverse reactions were directly related to EGFR inhibition or to idiosyncratic immune-related effects (e.g., Stevens-Johnson syndrome or toxic epidermal necrolysis). Advise males with female partners of reproductive potential to use effective contraception during treatment with ALIMTA and for 3 months after the final dose. The most common adverse reactions leading to discontinuation of any component of CYRAMZA with FOLFIRI as compared to placebo with FOLFIRI were neutropenia (12.5% vs 5.3%) and thrombocytopenia (4.2% vs 0.8%). For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. CYRAMZA, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Retevmo has not been studied in patients with clinically significant active cardiovascular disease or recent myocardial infarction. Episodes of diarrhea have been associated with dehydration and infection. AstraZeneca and Eli Lilly and Company (Lilly) today announced that they have entered into a clinical trial collaboration to evaluate the safety and preliminary efficacy of AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with ramucirumab (CYRAMZA®), Lilly’s VEGF Receptor 2 antiangiogenic cancer medicine. In patients with creatinine clearances between 45 mL/min and 79 mL/min, avoid administration of ibuprofen for 2 days before, the day of, and 2 days following administration of ALIMTA. The median time to first onset for increased AST was 4.1 weeks (range: 5 days to 2 years) and increased ALT was 4.1 weeks (range: 6 days to 1.5 years). Overall, 4.6% had their dose interrupted and 1.3% had their dose reduced for hypertension. The pharmacokinetics of Verzenio in patients with severe renal impairment (CLcr <30 mL/min), end stage renal disease, or in patients on dialysis is unknown. Eli Lilly will buy Loxo for $235 per share in cash—a 68% premium over Loxo’s most recent closing price. All rights reserved. If hypersensitivity occurs, withhold Retevmo and begin corticosteroids at a dose of 1 mg/kg. Severe adverse reactions (Grade 3-4) occurring in ≥15% of patients who received Retevmo in LIBRETTO-001, were hypertension (18%), prolonged QT interval (4%), diarrhea (3.4%), dyspnea (2.3%), fatigue (2%), abdominal pain (1.9%), hemorrhage (1.9%), headache (1.4%), rash (0.7%), constipation (0.6%), nausea (0.6%), vomiting (0.3%), and edema (0.3%). For assessment of potential hepatotoxicity, monitor liver function tests (LFTs) prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. The following sites were affected:  salivary glands (65% vs 56%), larynx (52% vs 36%), subcutaneous tissue (49% vs 45%), mucous membrane (48% vs 39%), esophagus (44% vs 35%), skin (42% vs 33%). About Eli Lilly and Company External Innovation. Latest Results for Verzenio in Hard-to-Treat Breast CancerLilly continues to investigate Verzenio across the breast cancer continuum, which has now shown positive results in people with high risk HR+, HER2- early breast cancer. The overall incidence of late radiation toxicities (any grade) was higher for patients receiving ERBITUX in combination with radiation therapy, versus radiation therapy alone. For patients with squamous histology, the overall incidence of pulmonary hemorrhage was 10% and the incidence of Grade ≥3 pulmonary hemorrhage was 2% for CYRAMZA with docetaxel compared to 12% overall incidence and 2% for Grade ≥3 pulmonary hemorrhage for placebo with docetaxel. In May 2020, TYVYT combined with gemcitabine and platinum chemotherapy met the predefined primary endpoint in the Phase 3 ORIENT-12 study as first-line therapy in patients with locally advanced or metastatic squamous NSCLC. If concomitant ibuprofen use cannot be avoided, monitor patients more frequently for ALIMTA adverse reactions, including myelosuppression, renal, and gastrointestinal toxicity. For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Advise pregnant women of the potential risk to a fetus. Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation. Withhold Retevmo for at least 7 days prior to elective surgery. The most common grade 3 and 4 adverse reactions (≥10%) included: fatigue (31% vs 29%), pain-other (18% vs 10%), rash/desquamation (16% vs 1%), dyspnea (16% vs 13%), other-gastrointestinal (12% vs 5%), and infection without neutropenia (11% vs 5%). Eli Lilly’s revamped oncology division, led by the former Loxo Oncology team, should have a meaningful contribution to future growth with selpercatinib. The risk of myelosuppression is increased in patients who do not receive vitamin supplementation. Venous thromboembolic events included deep vein thrombosis, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian and axillary vein thrombosis, and inferior vena cava thrombosis. In animal reproduction studies, intravenous administration of pemetrexed to pregnant mice during the period of organogenesis was teratogenic, resulting in developmental delays and increased malformations at doses lower than the recommended human dose of 500 mg/m2. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. for the uses being investigated. The most common adverse reactions (all Grades) observed in patients treated with CYRAMZA with erlotinib at a rate of ≥ 5% and ≥2% higher than placebo with erlotinib were infections (81% vs 76%), diarrhea (70% vs 71%), hypertension (45% vs 12%), stomatitis (42% vs 36%), alopecia (34% vs 20%), epistaxis (34% vs 12%), proteinuria (34% vs 8%), peripheral edema (23% vs 4%), headache (15% vs 7%), gastrointestinal hemorrhage (10% vs 3%), gingival bleeding (9% vs 1%), and pulmonary hemorrhage (7% vs 2%). INDIANAPOLIS, Sept. 10, 2020 /PRNewswire/ -- Data from 20 studies across Eli Lilly and Company's (NYSE: LLY) oncology product portfolio will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress, September 19-21, 2020. Two deaths due to neutropenic sepsis were observed in MONARCH 2. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with Retevmo and for 1 week after the final dose. Jason Mast Editor. Please see full U.S. Prescribing Information. IMPORTANT SAFETY INFORMATION FOR ERBITUX® (cetuximab), WARNING:  INFUSION REACTIONS AND CARDIOPULMONARY ARREST, Risks Associated with Use in Combination with Radiation and Cisplatin, Hypomagnesemia and Accompanying Electrolyte Abnormalities, Increased Tumor Progression, Increased Mortality, or Lack of Benefit in Patients with Ras--Mutant mCRC. CYRAMZA inhibited angiogenesis in an in vivo animal model. Strong and moderate CYP3A inhibitors increased the exposure of abemaciclib plus its active metabolites to a clinically meaningful extent and may lead to increased toxicity. With concomitant use of moderate CYP3A inhibitors, monitor for adverse reactions and consider reducing the Verzenio dose in 50 mg decrements. Withhold CYRAMZA for urine protein levels that are 2 or more grams over 24 hours. For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. © Lilly USA, LLC 2020. Twenty percent of patients treated with CYRAMZA with FOLFIRI received granulocyte colony- stimulating factors. Hepatocellular Carcinoma CYRAMZA, as a single agent, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib. Together, the studies presented at ESMO demonstrate Lilly's commitment to researching and developing new treatments for people around the world who are living with cancer. Coadministration of strong or moderate CYP3A inducers decreased the plasma concentrations of abemaciclib plus its active metabolites and may lead to reduced activity. Adverse reactions with fatal outcome were reported in 4% of patients in the ERBITUX combination arm and 3% in the control arm. CYRAMZA has the potential to adversely affect wound healing. Grade 3-5 IRR incidence was <1%. Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 1 were increased serum creatinine (98%; <1%), decreased white blood cells (91%; 28%), decreased neutrophil count (88%; 27%), anemia (68%; 0%), decreased lymphocyte count (42%; 14%), decreased platelet count (41%; 2%), increased ALT (31%; 3%), and increased AST (30%; 4%). Instruct patients that at the first sign of loose stools, they should start antidiarrheal therapy such as loperamide, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. The incidence of renal failure in clinical studies in which patients received ALIMTA as a single agent ranged from 0.4% to 0.6% (Studies JMEN. Avoid coadministration of Retevmo with CYP2C8 and CYP3A substrates where minimal concentration changes may lead to increased adverse reactions. Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 2 in ≥10% for Verzenio plus fulvestrant and ≥2% higher than placebo plus fulvestrant vs placebo plus fulvestrant were increased serum creatinine (98% vs 74%; 1% vs 0%), decreased white blood cells (90% vs 33%; 23% vs 1%), decreased neutrophil count (87% vs 30%; 33% vs 4%), anemia (84% vs 33%; 3% vs <1%), decreased lymphocyte count (63% vs 32%; 12% vs 2%), decreased platelet count (53% vs 15%; 2% vs 0%), increased ALT (41% vs 32%; 5% vs 1%), and increased AST (37% vs 25%; 4% vs 4%). ERBITUX can cause dermatologic toxicities, including acneiform rash, skin drying and fissuring, paronychial inflammation, infectious sequelae (e.g.. Acneiform rash occurred in 82% of the 1373 patients who received ERBITUX across clinical trials. Monitor patients receiving ERBITUX for dermatologic toxicities and infectious sequelae. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate. Avoid concomitant use of proton-pump inhibitors (PPIs), histamine-2 (H2) receptor antagonists, and locally-acting antacids with Retevmo. In MONARCH 3, the median time to first episode of Grade ≥3 neutropenia was 33 days, and in MONARCH 2 and MONARCH 1, was 29 days. Call (800) 545-5979, Lilly Oncology to Showcase New Data from Robust Cancer Research Pipeline at ESMO Virtual Congress 2020, http://www.prnewswire.com/news-releases/lilly-oncology-to-showcase-new-data-from-robust-cancer-research-pipeline-at-esmo-virtual-congress-2020-301127038.html. The time to onset and resolution for diarrhea were similar across MONARCH 3, MONARCH 2, and MONARCH 1. The most common adverse reactions (all grades, ≥10%) observed in MONARCH 3 for Verzenio plus anastrozole or letrozole and ≥2% higher than placebo plus anastrozole or letrozole vs placebo plus anastrozole or letrozole were diarrhea (81% vs 30%), neutropenia (41% vs 2%), fatigue (40% vs 32%), infections (39% vs 29%), nausea (39% vs 20%), abdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia (28% vs 5%), alopecia (27% vs 11%), decreased appetite (24% vs 9%), leukopenia (21% vs 2%), creatinine increased (19% vs 4%), constipation (16% vs 12%), ALT increased (16% vs 7%), AST increased (15% vs 7%), rash (14% vs 5%), pruritus (13% vs 9%), cough (13% vs 9%), dyspnea (12% vs 6%), dizziness (11% vs 9%), weight decreased (10% vs 3%), influenza-like illness (10% vs 8%), and thrombocytopenia (10% vs 2%). Retevmo is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). The most common adverse reactions (all grades; incidence ≥25%) seen in patients with K-Ras wild-type, EGFR-expressing mCRC treated with a cetuximab product in combination with FOLFIRI (n=317) versus FOLFIRI alone (n=350) (CRYSTAL) were acne-like rash (86% vs 13%), diarrhea (66% vs 60%), neutropenia (49% vs 42%), rash (44% vs 4%), stomatitis (31% vs 19%), anorexia (30% vs 23%), dermatitis acneiform (26% vs <1%) and pyrexia (26% vs 14%). Withhold ALIMTA for acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, or fever pending diagnostic evaluation. Treatment discontinuations due to adverse reactions occurred in 18% of CYRAMZA-treated patients, with proteinuria being the most frequent (2%). Eli Lilly’s acquisition of Loxo has added the FDA approved asset VITRAKVI and the early- and mid-stage oncology pipeline assets LOXO-305, LOXO-195, and LOXO-292. ALL RIGHTS RESERVED. In EXTREME, where a cetuximab product was administered in combination with platinum-based therapy, the addition cetuximab to cisplatin and fluorouracil resulted in an increased incidence of hypomagnesemia of any grade (14%) and of Grade 3 or 4 hypomagnesemia (7%). Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. Patients with NSCLC receiving therapeutic anticoagulation or with evidence of major airway invasion by cancer were excluded from REVEL. Reinitiate CYRAMZA at a reduced dose once the urine protein level returns to less than 2 grams over 24 hours. ALIMTA can cause severe, and sometimes fatal, renal toxicity. Monitor patients more frequently for myelosuppression, renal, and gastrointestinal toxicity, if concomitant administration of ibuprofen cannot be avoided. Retevmo is an oral prescription medicine, taken twice daily. ALIMTA (pemetrexed for injection) is not approved for use in combination with TYVYT in the United States. In patients who have had a dose reduction to 100 mg twice daily due to adverse reactions, further reduce the Verzenio dose to 50 mg twice daily with concomitant use of strong CYP3A inhibitors. Treatment discontinuation due to adverse reactions occurred more frequently in CYRAMZA with docetaxel-treated patients (9%) than in placebo with docetaxel-treated patients (5%). This site is intended for US Healthcare Professionals Only. Gastric Cancer CYRAMZA, as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. Monitor patients who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, and severe or uncontrolled heart failure. Instruct patients to limit sun exposure during ERBITUX therapy. Venous thromboembolic events were reported in 5% of patients treated with Verzenio plus fulvestrant in MONARCH 2 as compared to 0.9% of patients treated with fulvestrant plus placebo. Dose interruption or dose reduction is recommended in patients who develop persistent or recurrent Grade 2 ILD/pneumonitis. ILD, which was fatal in one case, occurred in <0.5% of 1570 patients receiving ERBITUX in clinical trials. For patients with non-squamous histology, the overall incidence of pulmonary hemorrhage was 7% and the incidence of Grade ≥3 pulmonary hemorrhage was 1% for CYRAMZA with docetaxel compared to 6% overall incidence and 1% for Grade ≥3 pulmonary hemorrhage for placebo with docetaxel. Retrospective subset analyses of Ras-mutant and wild-type populations across several randomized clinical trials, including CRYSTAL, were conducted to investigate the role of Ras mutations on the clinical effects of anti-EGFR-directed monoclonal antibodies. The safety and effectiveness of Retevmo have been established in pediatric patients aged 12 years and older for medullary thyroid cancer (MTC) who require systemic therapy and for advanced RET fusion-positive thyroid cancer who require systemic therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate). ACROFAN=Businesswire | webmaster@businesswire.com | SNS. TYVYT (sintilimab injection) is not an approved product in the United States. Do not administer CYRAMZA for at least 2 weeks following a major surgical procedure and until adequate wound healing. This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Lilly's oncology portfolio and pipeline, including Verzenio, Retevmo, CYRAMZA, TYVYT, ALIMTA, and ERBITUX, and reflects Lilly's current beliefs. Because of the potential risk for serious adverse reactions in breastfed children from ramucirumab, advise women not to breastfeed during treatment with CYRAMZA and for 2 months after the last dose. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. Grade 3-5 hemorrhage incidence ranged from 2-5%. Refer to: Courtney Kasinger; ckasinger@lilly.com; 317-501-7056 (Lilly) – media Kevin Hern; hern_kevin_r@lilly.com; 317-277-1838 (Lilly) – investors, View original content to download multimedia:http://www.prnewswire.com/news-releases/lilly-oncology-to-showcase-new-data-from-robust-cancer-research-pipeline-at-esmo-virtual-congress-2020-301127038.html, To speak to customer support: The most common adverse reactions leading to treatment discontinuation of CYRAMZA were proteinuria (1.5%), and gastrointestinal perforation (1.7%). Retevmo™ Data Highlights In May 2020, Lilly's first-in-class oral precision medicine Retevmo™ (selpercatinib) received Accelerated Approval from the U.S. Food and Drug Administration (FDA) for the treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC), in adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and in adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). In the ERBITUX arm, 2% experienced myocardial ischemia compared to 0.9% in the control arm. Grade 3-5 hypertension incidence ranged from 6-15%. All rights reserved. IMPORTANT SAFETY INFORMATION FOR ALIMTA® (pemetrexed for injection), Myelosuppression and Increased Risk of Myelosuppression Without Vitamin Supplementation, Increased Risk of Toxicity With Ibuprofen in Patients With Renal Impairment. Permanently discontinue ALIMTA for severe and life-threatening bullous, blistering, or exfoliating skin toxicity. The incidences of renal failure in clinical studies in which patients received ALIMTA with cisplatin were 2.1% in Study JMDB and 2.2% in Study JMCH. Clinical deterioration, manifested by new onset or worsening encephalopathy, ascites, or hepatorenal syndrome, was reported in patients with Child-Pugh B or C cirrhosis who received single agent CYRAMZA. The incidence of Grade 3 or 4 late radiation toxicities was similar between radiation therapy alone and the ERBITUX with radiation treatment groups.