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INDIANAPOLIS: Eli Lilly and Company has issued the following news release: Eli Lilly and Company (NYSE: LLY) today announced that data from studies of Verzenio(r) (abemaciclib; a CDK4/6 inhibitor), Retevmo(r) [...]

INDIANAPOLIS: Eli Lilly and Company has issued the following news release: Eli Lilly and Company (NYSE: LLY) today announced results from both the LIBRETTO-431 Phase 3 study, which evaluated Retevmo(r) [...]

ENPNewswire-October 23, 2023--Lilly's Retevmo Phase 3 Results in RET Fusion-Positive Non-Small Cell Lung Cancer and RET-Mutant Medullary Thyroid Cancer Both Published in The New England Journal of Medicine and Presented [...]

- In the Phase 3 LIBRETTO-431 study, Retevmo more than doubled progression-free survival (PFS) compared to chemotherapy plus pembrolizumab in patients with advanced or metastatic rearranged during transfection (RET) fusion-positive [...]

Eli Lilly and Company on 21 Oct 2023 announced results from both the LIBRETTO-431 Phase 3 study, which evaluated Retevmo (selpercatinib) versus platinum-based chemotherapy - with or without pembrolizumab - as an initial treatment for patients with advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the LIBRETTO-531 Phase 3 study, which evaluated Retevmo versus multikinase inhibitors (MKIs) in patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC). In both clinical studies, results were based on pre-specified interim efficacy analyses conducted by independent data monitoring committees (IDMC). Results from the LIBRETTO-431 and LIBRETTO-531 Phase 3 trials were presented in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2023 and simultaneously published in the New England Journal of Medicine. LIBRETTO-431 is a Phase 3, randomized, open-label trial that evaluated Retevmo in patients with advanced or metastatic, treatment-naive RET fusion-positive NSCLC. In the ITT-pembrolizumab population, the median PFS by BICR was 24.8 months with Retevmo versus 11.2 months in the control arm, corresponding to a hazard ratio (HR) of 0.465. PFS was longer with Retevmo than in the control arm across all pre-specified subgroups. The overall response rate (ORR) by BICR with Retevmo was 83.7% compared to 65.1% in the control arm. Similar results were observed in the ITT population in both BICR and investigator-assessed endpoints and across all pre-specified subgroups. Retevmo demonstrated superior PFS with an HR of 0.482 and an increase of more than 13 months in median PFS by BICR, showing 24.8 months with Retevmo versus 11.2 months with control. Overall survival (OS) results remain immature with a censoring rate of approximately 80% in the ITT-pembrolizumab arm. LIBRETTO-531 is a Phase 3, randomized, open-label trial that evaluated Retevmo versus physician's choice of MKIs cabozantinib or vandetanib, which are currently approved first-line options for patients with advanced or metastatic, kinase inhibitor-naive RET-mutant MTC. At the interim analysis, the study had met the criteria for positive PFS. At a median follow-up of approximately 12 months, the BICR-assessed median PFS in the Retevmo arm was not reached and remained inestimable, whereas the BICR-assessed median PFS in the control arm was 16.8 months. This corresponded to a HR of 0.280. Investigator-assessed PFS yielded similar results with an HR of 0.187. Both BICR and investigator-assessed PFS were longer with Retevmo across all pre-planned subgroups. Original source: Eli Lilly, website: http://www.lilly.com/, Copyright Eli Lilly and Company 2023., research and development; anticancer drugs; cabozantinib; monoclonal antibodies; pembrolizumab; Retevmo; selpercatinib; vandetanib; Eli Lilly and [...]

CAMBRIDGE: Foundation Medicine Inc has issued the following news release: Foundation Medicine Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne(r)CDx [...]

ENPNewswire-October 10, 2023--Foundation Medicine Inc. - U.S. Food and Drug Administration Approves FoundationOneCDx as a Companion Diagnostic for Lilly's Retevmo for Certain Patients with Solid Tumors (C)2023 ENPublishing - http://www.enpublishing.co.uk [...]

INDIANAPOLIS: Eli Lilly and Company has issued the following news release: Eli Lilly and Company (NYSE: LLY) today announced that data from studies of Verzenio(r) (abemaciclib; a CDK4/6 inhibitor), Retevmo(r) [...]

Foundation Medicine's tissue-based comprehensive genomic profiling test is now FDA approved to identify patients with solid tumors with RET gene fusions who may benefit from treatment with Retevmo CAMBRIDGE, Mass. [...]

ENPNewswire-October 9, 2023--Lilly Announces Details of Presentations at ESMO Congress 2023 (C)2023 ENPublishing - http://www.enpublishing.co.uk Release date- 06102023 - INDIANAPOLIS - Eli Lilly and Company (NYSE: LLY) today announced that [...]

INDIANAPOLIS, Oct. 6, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data from studies of Verzenio(abemaciclib; a CDK4/6 inhibitor), Retevmo(selpercatinib; a rearranged during transfection [RET] inhibitor), [...]

2023 NOV 7 (NewsRx) -- By a News Reporter-Staff News Editor at Cancer Weekly -- Eli Lilly and Company (NYSE: LLY) announced results from both the LIBRETTO-431 Phase 3 study, [...]

Approval also marks the second NGS-based companion diagnostic to identify RET-fusion positive locally advanced or metastatic non-small cell lung cancer (NSCLC) The U.S. Food and Drug Administration (FDA) has granted [...]

Waltham: Thermo Fisher Scientific, Inc. (TMO) has issued the following press release: The U.S. Food and Drug Administration (FDA) has granted approval to Thermo Fisher Scientific's Oncomine Dx Target Test [...]

Approval also marks the second NGS-based companion diagnostic to identify RET-fusion positive locally advanced or metastatic non-small cell lung cancer (NSCLC) CARLSBAD, Calif. -- The U.S. Food and Drug Administration [...]

INDIANAPOLIS: Eli Lilly and Company has issued the following news release: Eli Lilly and Company ( NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) has granted approval [...]

Eli Lilly and Company on 21 Sep 2022 announced the US Food and Drug Administration (FDA) has granted approval to Retevmo (selpercatinib, 40 mg & 80 mg capsules) for adult patients with locally advanced or metastatic solid tumours with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on ORR and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. Original source: Eli Lilly, website: http://www.lilly.com/, Copyright Eli Lilly and Company 2022., regulations and rulings; anticancer drugs; Retevmo; selpercatinib; Eli Lilly and [...]

Tumor-agnostic data supporting approval demonstrated an overall response rate (ORR) of 44% across multiple tumor types FDA simultaneously grants traditional approval in adults with locally advanced or metastatic non-small cell [...]

INDIANAPOLIS: Eli Lilly and Company has issued the following news release: Eli Lilly and Company ( NYSE: LLY) today announced that data from studies of Verzenio(r) (abemaciclib) and Retevmo(r) (selpercatinib) [...]

INDIANAPOLIS: Eli Lilly and Company has issued the following news release: Eli Lilly and Company (NYSE: LLY) today announced that data from its oncology portfolio will be presented at the [...]

INDIANAPOLIS, May 26, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data from its oncology portfolio will be presented at the 2022 American Society of Clinical [...]

Lilly's revenue growth in Q1 2022 increased 15%, driven by volume growth of 20%. Excluding revenue from COVID-19 antibodies and Alimta, Q1 2022 revenue grew 10%. Outside of revenue from [...]

INDIANAPOLIS: Eli Lilly and Company has issued the following news release: Eli Lilly and Company (NYSE: LLY) today announced updated data from the Phase 1/2 LIBRETTO-001 trial of Retevmo(r) (selpercatinib [...]

INDIANAPOLIS, April 1, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced updated data from the Phase 1/2 LIBRETTO-001 trial of Retevmo (selpercatinib 40 mg & 80 mg [...]

Eli Lilly and Company on 1 Apr 2022 announced updated data from the Phase 1/2 LIBRETTO-001 trial of Retevmo (selpercatinib 40 mg & 80 mg capsules) in patients with RET fusion-positive non-small cell lung cancer (NSCLC). Retevmo is a selective and potent RET kinase inhibitor that is approved in multiple countries including the United States for treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive NSCLC, and the treatment of adult and paediatric 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). These data were presented at the European Lung Cancer (ELCC) 2022 (poster 27p). Among 247 patients previously treated with platinum chemotherapy, the confirmed objective response rate (ORR) was 61.1% and among 69 treatment-naive patients, the confirmed ORR was 84.1%. Twenty-six patients had measurable central nervous system (CNS) metastases at baseline and treatment with Retevmo resulted in a CNS ORR of 84.6%, with 22 patients having a confirmed best response of complete response or partial response. At a median follow-up of approximately two years in both the treatment-naive and platinum-chemotherapy pretreated populations, median duration of response (DoR) is estimated at 20.2 (55.2% censoring rate; 20.3 months median duration of follow-up) and 28.6 (60.9% censoring rate; 21.2 months median duration of follow-up) months, respectively and median progression free survival (PFS) is estimated at 22.0 (53.6% censoring rate; 21.9 months median duration of follow-up) and 24.9 (55.9% censoring rate; 24.7 months median duration of follow-up) months, respectively. Of the 26 patients with measurable CNS disease, Retevmo treatment resulted in a median intracranial PFS of 19.4 months. These median estimates remain immature. Safety among patients in this cohort was consistent with the known safety profile of Retevmo. In the safety population (all NSCLC patients that received at least one dose of Retevmo, N=356), the most common adverse events (AEs in ?25% of patients) were dry mouth, diarrhoea, hypertension, increased ALT/AST, peripheral oedema, constipation, rash, headache, and fatigue. Thirty-four patients discontinued due to an adverse event (10%), eleven (3%) of which were deemed related to Retevmo. Original source: Eli Lilly, website: http://www.lilly.com/, Copyright Eli Lilly and Company 2022., research and development; anticancer drugs; Retevmo; selpercatinib; Eli Lilly and [...]

SAN FRANCISCO and INDIANAPOLIS and SUZHOU, China, March 27, 2022 /PRNewswire/ -- Innovent Biologics, Inc. ('Innovent', HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for [...]

2022 OCT 3 (NewsRx) -- By a News Reporter-Staff News Editor at Pharma Business Week -- Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) [...]

M2 PHARMA-September 28, 2022-Thermo Fisher Scientific Announces FDA Approval of Oncomine Dx Target Test as the First NGS-Based Companion Diagnostic to Aid in Therapy Selection for Patients with RET Mutations/Fusions [...]

CAMBRIDGE, Mass.: Foundation Medicine, Inc. announced a collaboration with Eli Lilly and Company (Lilly) for the development of Foundation Medicine's tissue- and blood-based assays as companion diagnostics for RETEVMO(r) and [...]

CAMBRIDGE, Mass. -- Foundation Medicine, Inc. today announced a collaboration with Eli Lilly and Company (Lilly) for the development of Foundation Medicine's tissue- and blood-based assays as companion diagnostics for [...]

INDIANAPOLIS: Eli Lilly and Company has issued the following news release: Eli Lilly and Company (NYSE: LLY) announced financial results for the fourth quarter and full year of 2021 today. [...]

- Revenue in the fourth quarter of 2021 increased 8 percent, driven by volume growth of 11 percent. Excluding COVID-19 antibodies, fourth-quarter 2021 revenue grew 6 percent. - Full-year 2021 [...]