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). 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%). At Lilly Oncology, some of us have been touched by cancer one way or another—either as a patient or as a caregiver, relative, or friend of a patient. Copyright © 2021 Eli Lilly and Company. The risk of myelosuppression is increased in patients who do not receive vitamin supplementation. Grade 3-5 hemorrhage incidence ranged from 2-5%. Treatment discontinuation of any study drug due to adverse reactions occurred more frequently in CYRAMZA with FOLFIRI-treated patients (29%) than in placebo with FOLFIRI-treated patients (13%). For all FDA-approved indications for ALIMTA, please see full Prescribing Information. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Please see full U.S. Prescribing Information for CYRAMZA. Severe (Grades 3 or 4) acneiform rash occurred in 9.7% of patients. Monitor blood pressure every two weeks or more frequently as indicated during treatment. Coadministration of strong or moderate CYP3A inducers decreased the plasma concentrations of abemaciclib plus its active metabolites and may lead to reduced activity. In MONARCH 2, for patients receiving Verzenio plus fulvestrant with Grade ≥3 increases in ALT or AST, median time to onset was 57 and 185 days, respectively, and median time to resolution to Grade <3 was 14 and 13 days, respectively. Upon resolution of the event, resume Retevmo at a reduced dose and increase the dose of Retevmo by 1 dose level each week as tolerated until reaching the dose taken prior to onset of hypersensitivity. not been established. Permanently discontinue CYRAMZA for urine protein levels greater than 3 grams over 24 hours or in the setting of nephrotic syndrome. To date, more than 150,000 patients have been treated with CYRAMZA. Monitor blood pressure after 1 week, at least monthly thereafter, and as clinically indicated. Overall, 4.6% had their dose interrupted and 1.3% had their dose reduced for hypertension. 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. In MONARCH 3, the median time to onset of the first diarrhea event was 8 days, and the median duration of diarrhea for Grades 2 and 3 were 11 and 8 days, respectively. About Lilly Oncology 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. ALIMTA can cause severe, and sometimes fatal, renal toxicity. There are no available data for ERBITUX exposure in pregnant women. With this approval, CYRAMZA has now received six FDA approvals to treat certain types of lung, liver, stomach and colorectal cancers. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA. Both Phase 3 trials are currently enrolling patients. TYVYT has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin's lymphoma after at least two lines of systemic chemotherapy and was included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. 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. In an animal reproduction study, intravenous administration of cetuximab once weekly to pregnant cynomolgus monkeys during the period of organogenesis resulted in an increased incidence of embryolethality and abortion. Grade 3-5 IRR incidence was <1%. Hypomagnesemia occurred in 55% of 365 patients receiving ERBITUX in study CA225-025 and two other clinical trials in patients with colorectal cancer (CRC) or head and neck cancer, including Grades 3 and 4 in 6% to 17%. The most common adverse reactions (all grades; incidence ≥25%) seen in patients with K-Ras wild-type, EGFR-expressing mCRC treated with ERBITUX + best supportive care (BSC) (n=118) versus BSC alone (n=124) (CA225-025) were rash/desquamation (95% vs 21%), fatigue (91% vs 79%), nausea (64% vs 50%), pain-other (59% vs 37%), dry skin (57% vs 15%), constipation (53% vs 38%), dyspnea (49% vs 44%), pruritis (47% vs 11%), neuropathy-sensory (45% vs 38%), diarrhea (42% vs 23%), vomiting (40% vs 26%), headache (38% vs 11%), infection without neutropenia (38% vs 19%), other-dermatology (35% vs 7%), stomatitis (32% vs 10%), nail changes (31% vs 4%), cough (30% vs 19%), insomnia (27% vs 13%) and fever (25% vs 16%). The most common adverse reactions leading to treatment discontinuation of CYRAMZA were IRR (0.5%) and epistaxis (0.3%). Withhold CYRAMZA for 28 days prior to elective surgery. The onset of hypomagnesemia and accompanying electrolyte abnormalities can occur days to months after initiating ERBITUX. The most common adverse reactions (all Grades) observed in patients treated with CYRAMZA with FOLFIRI at a rate of ≥5% and ≥2% higher than placebo with FOLFIRI were diarrhea (60% vs 51%), neutropenia (59% vs 46%), decreased appetite (37% vs 27%), epistaxis (33% vs 15%), stomatitis (31% vs 21%), thrombocytopenia (28% vs 14%), hypertension (26% vs 9%), peripheral edema (20% vs 9%), proteinuria (17% vs 5%), palmar-plantar erythrodysesthesia syndrome (13% vs 5%), gastrointestinal hemorrhage events (12% vs 7%), and hypoalbuminemia (6% vs 2%). If hypersensitivity occurs, withhold Retevmo and begin corticosteroids at a dose of 1 mg/kg. Avoid concomitant use of the strong CYP3A inhibitor ketoconazole. Verzenio can cause fetal harm when administered to a pregnant woman based on findings from animal studies and the mechanism of action. Optimize blood pressure prior to initiating Retevmo. CYRAMZA can increase the risk of gastrointestinal perforation, a potentially fatal event. "We're thrilled to share the statistically significant and clinically meaningful results from monarchE, a Phase 3 study which demonstrated the impact of Verzenio, in combination with adjuvant endocrine therapy, to reduce the risk of cancer returning and potentially change the treatment landscape in high risk early breast cancer," said Maura Dickler, M.D., vice president, late phase development, Lilly Oncology. Disruption or depletion of EGFR in animal models results in impairment of embryo-fetal development including effects on placental, lung, cardiac, skin, and neural development. 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. Treatment discontinuation due to adverse reactions occurred more frequently in CYRAMZA with docetaxel-treated patients (9%) than in placebo with docetaxel-treated patients (5%). The most common adverse reactions (all grades, ≥10%) observed in MONARCH 1 with Verzenio were diarrhea (90%), fatigue (65%), nausea (64%), decreased appetite (45%), abdominal pain (39%), neutropenia (37%), vomiting (35%), infections (31%), anemia (25%), thrombocytopenia (20%), headache (20%), cough (19%), leukopenia (17%), constipation (17%), arthralgia (15%), dry mouth (14%), weight decreased (14%), stomatitis (14%), creatinine increased (13%), alopecia (12%), dysgeusia (12%), pyrexia (11%), dizziness (11%), and dehydration (10%). Limitation of Use: ALIMTA is not indicated for the treatment of patients with squamous cell non-small cell lung cancer. 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%). Clinically relevant adverse reactions reported in ≥1% and <10% of CYRAMZA-treated patients in REACH-2 were IRR (9%), hepatic encephalopathy (5%) including 1 fatal event, and hepatorenal syndrome (2%) including 1 fatal event. Oncology Pipeline. 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. The addition of ERBITUX to radiation and cisplatin did not improve progression-free survival (the primary endpoint). At ESMO, Lilly will share detailed results from the Phase 3 monarchE study, which demonstrated Verzenio plus standard adjuvant ET significantly decreased the risk of breast cancer recurrence compared to standard adjuvant ET alone in people with high risk HR+, HER2- early breast cancer. 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. 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%). Grade 3-5 ATE incidence was <1-2%. Dose interruption, dose reduction, dose discontinuation, or delay in starting treatment cycles is recommended for patients who develop persistent or recurrent Grade 2, or Grade 3 or 4, hepatic transaminase elevation. In vitro, continuous exposure to Verzenio inhibited Rb phosphorylation and blocked progression from G1 to S phase of the cell cycle, resulting in senescence and apoptosis (cell death). In 2137 patients with various cancers treated with CYRAMZA, the incidence of all Grade hemorrhage ranged from 13-55%. Withhold ALIMTA in patients with a creatinine clearance of less than 45 mL/min. Eli Lilly has 7 approved drugs in its oncology portfolio including Cyramza, Verzenio, Erbitux, Portrazza, Gemzar, and Retevmo. Clinically relevant adverse reactions reported in ≥1% and <5% of CYRAMZA-treated patients in REGARD were neutropenia (4.7%), epistaxis (4.7%), rash (4.2%), intestinal obstruction (2.1%), and arterial thromboembolic events (1.7%). If pneumonitis is confirmed, permanently discontinue ALIMTA. Jason Mast Editor. Advise females of reproductive potential to use effective contraception during treatment with Verzenio and for at least 3 weeks after the last dose. Confirm Ras mutation status in tumor specimens prior to initiating ERBITUX. 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 REGARD, according to laboratory assessment, 8% of CYRAMZA-treated patients developed proteinuria vs 3% of placebo-treated patients. Obtain a complete blood count at the beginning of each cycle. Permanently discontinue Retevmo for recurrent hypersensitivity. Episodes of diarrhea have been associated with dehydration and infection. Assess QT interval, electrolytes and TSH at baseline and periodically during treatment, adjusting frequency based upon risk factors including diarrhea. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia. 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). 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%). Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. Abstract LBA5_PR: Abemaciclib in high risk early breast cancer (Stephen R. Johnston) Accepted for Presidential Symposium II September 20 at 19:51-20:03 CEST, Abstract 273O: nextMONARCH: Final overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with HR+, HER2- metastatic breast cancer (Erika P. Hamilton) Accepted as Oral Presentation September 19 at 17:28-17:40 CEST; Session: Breast Cancer, Metastatic 1, Abstract 174P: Genomic testing, biomarkers and treatment patterns in early breast cancer (Michael Method) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 181P: The use of Ki67 testing and scoring in HR+, HER2- early breast cancer (Jacqueline Brown) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 240P: A multinational real-world study on HR+, HER2- early stage breast cancer patients' disease awareness, satisfaction, and involvement in treatment decisions (Alex Rider) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 239P: Impact of clinical characteristics, patients' perception of treatment goals and endocrine therapy history on HRQOL in HR+, HER2- early stage breast cancer patients (Rhys Williams) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1291P: Hypersensitivity reactions (HR) to selpercatinib in RET fusion+ non-small cell lung cancer (NSCLC) patients (pts) following immune checkpoint inhibition (CPI) (Caroline E. McCoach) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1290P: Efficacy and safety with selpercatinib by last prior systemic therapy received in patients (Pts) with RET fusion + non-small cell lung cancer (NSCLC) (Oliver Gautschi) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1292P: Exploratory patient-reported outcomes (PROs) among patients with RET-fusion non-small cell lung cancer (NSCLC) in LIBRETTO-001: A phase I/II trial of selpercatinib (Anna R. Minchom) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1922P: Exploratory patient-reported outcomes among patients with RET-mutant medullary thyroid cancer in LIBRETTO-001: A phase I/II trial of selpercatinib (LOXO-292) (Lori J. Wirth) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1413TiP: LIBRETTO-431: Selpercatinib in treatment (Tx)-naïve patients with RET fusion-positive (RET+) non-small cell lung cancer (NSCLC) (Herbert H. Loong) Accepted as ePoster (trial in progress; no data will be presented) Available on-demand on September 17 at 09:00 CEST, Abstract 1927TiP: LIBRETTO-531: Selpercatinib in patients with treatment (Tx)-naïve RET-mutant medullary thyroid cancer (MTC) (Jorge Hernando) Accepted as ePoster (trial in progress; no data will be presented) Available on-demand on September 17 at 09:00 CEST, Abstract 1294P: RELAY, erlotinib plus ramucirumab or placebo in untreated EGFR-mutated metastatic NSCLC: Outcomes by EGFR mutation type (Kazuhiko Nakagawa) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1357P: Outcomes of treated patients with EGFR-mutated advanced or metastatic non-small cell lung cancer harboring exon 19 deletions or L858R substitution (Exon 21) mutations: A systematic literature review (Katherine B. Winfree) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1298P: RELAY, ramucirumab plus erlotinib (RAM+ERL) versus placebo plus erlotinib (P+ERL) in untreated EGFR mutated metastatic non-small cell lung cancer (NSCLC): Exposure-response relationship (Kazuhiko Nakagawa) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1015TiP: Ramucirumab in patients with advanced hepatocellular carcinoma and elevated alpha fetoprotein following a non-sorafenib based systemic therapy: An expansion cohort of the phase III REACH-2 study (Richard S. Finn) Accepted as ePoster (trial in progress; no data will be presented) Available on-demand on September 17 at 09:00 CEST, Abstract 991P: Sintilimab plus IBI305 as first-line treatment for advanced hepatocellular carcinoma (Fan Jia) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 1498TiP: A multi-center, randomized, open-label, phase III study of sintilimab + ramucirumab as 1st-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ORIENT-106) (Ruihua Xu) Accepted as ePoster (trial in progress; no data will be presented) Available on-demand on September 17 at 09:00 CEST, Abstract 1313P: Phase III LEAP-006 safety run-in (Part 1): 1L pembrolizumab (Pembro) + chemotherapy (Chemo) with lenvatinib (Len) for metastatic NSCLC (Makoto Nishio) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST, Abstract 455P: A meta-analysis of efficacy and safety of cetuximab with biweekly vs. weekly dosing (Aparna Parikh) Accepted as ePoster Available on-demand on September 17 at 09:00 CEST. The safety and efficacy of the agents under investigation have If a patient taking Verzenio discontinues a strong CYP3A inhibitor, increase the Verzenio dose (after 3 to 5 half-lives of the inhibitor) to the dose that was used before starting the inhibitor. If coadministration cannot be avoided, take Retevmo with food (with a PPI) or modify its administration time (with a H2 receptor antagonist or a locally-acting antacid). There is no guarantee that the agents will 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. 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 strong and moderate CYP3A inducers. 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). NSCLC, Medullary Thyroid Cancer, Papillary Thyroid Carcinoma, or Other Advanced Solid Tumors, United States and Canadian Academy of Pathology Annual Meeting, St. Gallen International Breast Cancer Conference, American Association for Cancer Research Annual Meeting. Serious interstitial pneumonitis, including fatal cases, can occur with ALIMTA treatment. 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 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. Advise pregnant women of the potential risk to a fetus. Folic acid and vitamin B12 supplementation should be continued during treatment and for 21 days after the last dose of ALIMTA as they may reduce the severity of treatment-related hematologic and gastrointestinal toxicities. Monitor the QT interval more frequently when Retevmo is concomitantly administered with strong and moderate CYP3A inhibitors or drugs known to prolong QTc interval. Clinically relevant adverse reactions reported in ≥1% and <5% of patients receiving CYRAMZA with paclitaxel were sepsis (3.1%), including 5 fatal events, and gastrointestinal perforations (1.2%), including 1 fatal event. Withhold, reduce dose or permanently discontinue ERBITUX based on severity of acneiform rash or mucocutaneous disease. The most common grade 3 and 4 adverse reactions (≥10%) included: neutropenia (31% vs 24%), acne-like rash (18% vs <1%), and diarrhea (16% vs 10%). The most common adverse reactions (all grades) seen in patients with EGFR-expressing recurrent mCRC (n=354) treated with ERBITUX plus irinotecan in clinical trials (CP02-9923 and BOND) were acneiform rash (88%), asthenia/malaise (73%), diarrhea (72%), and nausea (55%). Details on the study design of two confirmatory Phase 3 trials, LIBRETTO-431 and LIBRETTO-531, will additionally be shared. The most common adverse reactions (all Grades) observed in patients treated with CYRAMZA with paclitaxel at a rate of ≥5% and ≥2% higher than placebo with paclitaxel were fatigue/asthenia (57% vs 44%), neutropenia (54% vs 31%), diarrhea (32% vs 23%), epistaxis (31% vs 7%), hypertension (25% vs 6%), peripheral edema (25% vs 14%), stomatitis (20% vs 7%), proteinuria (17% vs 6%), thrombocytopenia (13% vs 6%), hypoalbuminemia (11% vs 5%), and gastrointestinal hemorrhage events (10% vs 6%). Treatment discontinuation of all study drugs due to adverse reactions occurred in 13% of CYRAMZA with erlotinib-treated patients, with increased alanine aminotransferase (1.4%) and paronychia (1.4%) being the most common. Fatal adverse reactions occurred in 3% of patients; fatal adverse reactions which occurred in > 1 patient included sepsis (n = 3), cardiac arrest (n = 3) and respiratory failure (n = 3). Patients with gastric cancer receiving nonsteroidal anti-inflammatory drugs (NSAIDs) were excluded from enrollment in REGARD and RAINBOW; therefore, the risk of gastric hemorrhage in CYRAMZA-treated patients with gastric tumors receiving NSAIDs is unknown. In 221 patients with NSCLC receiving CYRAMZA in combination with erlotinib in the RELAY study, the incidence of new or worsening hypertension was higher (45%), as was the incidence of Grade 3-5 hypertension (24%). In MONARCH 3, median duration of Grade ≥3 neutropenia was 11 days, and for MONARCH 2 and MONARCH 1 was 15 days. All rights reserved. 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. With concomitant use of moderate CYP3A inhibitors, monitor for adverse reactions and consider reducing the Verzenio dose in 50 mg decrements. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. 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. Retevmo may affect both tumor cells and healthy cells, which can result in side effects. The addition of ERBITUX resulted in an increase in the incidence of Grade 3 and 4 mucositis, radiation recall syndrome, acneiform rash, cardiac events, and electrolyte disturbances compared to radiation and cisplatin alone. If coadministration cannot be avoided, follow recommendations for CYP2C8 and CYP3A substrates provided in their approved product labeling. Acneiform rash usually developed within the first 2 weeks of therapy; the rash lasted more than 28 days after stopping ERBITUX in most patients. Lilly has a robust oncology pipeline that includes both small molecules and monoclonal antibodies, which are being studied to treat a wide range of cancers including breast, colorectal, liver and non-small cell lung. The rate of gastrointestinal perforation in REGARD was 0.8% and the rate of IRR was 0.4%. The approval of Retevmo – a selective RET kinase inhibitor – marked the most rapid timeline in the development of an oncology medicine with multiple indications, and was based on results from the Phase 1/2 LIBRETTO-001 trial, the largest clinical trial in patients with RET-altered cancers. ALIMTA®, CYRAMZA®, ERBITUX®, Retevmo™ and Verzenio® are trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates. 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. Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 3 in ≥10% for Verzenio plus anastrozole or letrozole and ≥2% higher than placebo plus anastrozole or letrozole vs placebo plus anastrozole or letrozole were increased serum creatinine (98% vs 84%; 2% vs 0%), decreased white blood cells (82% vs 27%; 13% vs <1%), anemia (82% vs 28%; 2% vs 0%), decreased neutrophil count (80% vs 21%; 22% vs 3%), decreased lymphocyte count (53% vs 26%; 8% vs 2%), decreased platelet count (36% vs 12%; 2% vs <1%), increased ALT (48% vs 25%; 7% vs 2%), and increased AST (37% vs 23%; 4% vs <1%).
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