FDA approves J&J`s combination therapy for a type of lung cancer
INDIANAPOLIS, Aug. 4, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced topline results from the LIBRETTO-431 study evaluating Retevmo versus platinum-based chemotherapy plus pemetrexed – with or without pembrolizumab – as an initial treatment for patients with rearranged during transfection (RET) fusion-positive advanced or metastatic non-small cell lung cancer (NSCLC). The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS). This result was based on a pre-specified interim efficacy analysis conducted by an independent data monitoring committee (IDMC). Adverse events observed on Retevmo were generally consistent with those identified across the previously reported Retevmo development program (LIBRETTO-001, LIBRETTO-121, LIBRETTO-321).
Intas Pharmaceuticals Limited on FDA Import Alert List
Baxter`s Pemetrexed Receives Approval in Europe
Taiwan's Lotus Pharmaceuticals has announced that its Board of Directors has approved the acquisition of the trademark, marketing authorization, and manufacturing know-how of Pemetrexed 100mg and 500mg under the brand name of Alimta in Taiwan for $62 million from Eli Lilly and Company.
SHANGHAI, China, Sept. 20, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the China National Medical Products Administration (“NMPA”) has approved the supplemental new drug application (“sNDA”) for toripalimab in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (“NSCLC”). This is the sixth indication approved for toripalimab in China and will bring more treatment options to Chinese patients with advanced NSCLC.
TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) announced today that the first patient has been dosed in the global HERTHENA-Lung02 phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan (HER3-DXd) versus platinum-based chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with disease progression following treatment with one or more EGFR tyrosine kinase inhibitors (TKIs) including a third-generation EGFR TKI.
Even as Eli Lilly puts much of its energy behind a suite of new drug launches, an older cancer medicine that just tumbled off the patent cliff is proving to be a big drag on the company's financial performance.