The FDA has given a green light to Foundation Medicine Inc.’s Foundationone CDx as a companion diagnostic for Takeda Pharmaceutical Co. Ltd.’s Alunbrig to identify patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small-cell lung cancer (NSCLC). The approval comes as Laboratory Corp. of America Holdings (Labcorp) is launching a companion diagnostic to identify NSCLC patients with the KRAS mutation. NSCLC accounts for about 85% of all lung cancers, with an estimated 1.8 million new cases diagnosed each year worldwide. Of those, 3% to 5% carry the ALK gene mutation, which is often missed with standard testing methods.
Arrivent Biopharma Inc. has raised a series A financing worth up to $150 million to in-license compounds from China and bring them to the rest of the world. Arrivent’s focus is in oncology and its first in-licensed asset is furmonertinib, a third-generation EFGR tyrosine kinase inhibitor from Shanghai-based Allist Pharmaceuticals Co. Ltd.
Hutchmed Ltd.’s savolitinib became the first selective MET inhibitor approved in China to treat patients with non-small-cell lung cancer with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
Wall Street must wait a while longer to find out if Gilead Sciences Inc. will exercise its $275 million option for Arcus Biosciences Inc.’s TIGIT binder, domvanalimab. Meanwhile, investors took heart from an optimistic – albeit vague – interim report on the phase II ARC-7 trial.
Hutchmed Ltd.’s savolitinib became the first selective MET inhibitor approved in China to treat patients with non-small-cell lung cancer with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
Shares of Cullinan Oncology Inc. (NASDAQ:CGEM) rose 11.3% to close at $33.11 on June 4 as an update on its EGFR inhibitor, CLN-081, suggested it may prove competitive with Johnson & Johnson's recently approved treatment, Rybrevant (amivantamab), for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations.
Amgen Inc.’s Merdo Gordon, head of commercial global operations, said just-approved Lumakras (sotorasib) is “priced very well compared to other targeted medicines available in the market” for cancers driven by specific mutations. “Just characterizing the launch broadly, look, it’s really hard to tell because of the variability of our reach to customers right now” – a result of the COVID-19 pandemic.
Well ahead of the assigned Aug. 16 PDUFA date, Amgen Inc. bagged accelerated clearance from the FDA for Lumakras (sotorasib), the first targeted therapy for adults with KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC), as determined by an FDA-approved test.
Locust Walk Acquisition Corp. CEO and biotech veteran Chris Ehrlich said his firm sifted through more than 90 prospects before setting on a merger with Effector Therapeutics Inc., focused on selective translation regulation inhibitors (STRIs) in cancer.
The FDA’s approval for Johnson & Johnson (J&J) of Rybrevant (amivantamab-vmjw) not only brings the first treatment for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations, but also sets a high overall response rate bar for other developers in the space.
