Pillar Biosciences LLC hopes to build a stronger foundation for its multi-cancer in vitro diagnostic, Oncoreveal Dx. The company filed a supplemental application for U.S. FDA premarket approval of eight additional types of cancer, which the agency accepted for review. The assay received FDA premarket approval for use in non-small cell lung cancer (NSCLC) and colon cancer in August 2021.
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.
On June 17, the FDA approved checkpoint blocker Keytruda (pembrolizumab, Merck & Co. Inc.) “for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [?10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.”
With a coronavirus task force briefing unfolding at the White House late on April 17, an FDA eager to show its ongoing commitment to tackling other disease amid the pandemic, granted accelerated approval to Incyte Corp.'s Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma.
Foundation Medicine Inc.'s pan-cancer detection test has received a nod from the FDA, making it one of the most comprehensive companion diagnostics to receive approval from the agency. Concurrent with FDA approval, the Centers for Medicare and Medicaid Services issued a preliminary National Coverage Determination (NCD) for the Foundationone Cdx.
