The FDA has approved FoundationOne® CDx (Foundation Medicine, Inc.) as a companion diagnostic device to identify neurotrophic receptor tyrosine kinase (NTRK) fusions in patients with solid tumors in order to determine eligibility for treatment with larotrectinib (Vitrakvi®, Bayer Healthcare Pharmaceuticals, Inc.). FoundationOne is a next-generation sequencing (NGS)-based in vitro diagnostic device previously approved to determine eligibility for more than 20 other FDA-approved targeted therapies...
The FDA has now granted full approval to venetoclax (Venclexta®, AbbVie Inc. and Genentech Inc.) in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for patients with previously untreated acute myeloid leukemia (AML) who are at least 75 years of age or who have comorbidities that prevent them from receiving intensive induction chemotherapy. Previously, this venetoclax combination therapy was granted accelerated approval in 2018 for use in this same patient population. The ...
PembrolizumabThe FDA has now expanded the approved indications for pembrolizumab (KEYTRUDA®, Merck Sharp & Dohme) to include both adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) and pediatric patients with refractory cHL, or cHL that has relapsed after two or more lines of therapy. The approval was based on efficacy data from the open-label phase 3 KEYNOTE-204 trial (NCT02684292), for which 304 adult patients with cHL previously treated with at least one multiagen...
The FDA has issued draft guidance documents for drug and biologic development in the adjuvant treatment of renal cell carcinoma (RCC) and bladder cancer, with recommendations for clinical trials concerning eligibility criteria, methodology, and use of disease-free survival as an end point. "The FDA has actively encouraged a more uniform approach to developing clinical trials to evaluate adjuvant treatments for renal cell carcinoma and bladder cancer, including hosting a public workshop in p...
The FDA has now approved nivolumab (Opdivo®, Bristol Myers Squibb) in combination with ipilimumab (Yervoy®, Bristol-Myers Squibb) as first-line treatment for unresectable malignant pleural mesothelioma (MPM). This therapeutic combination is only the second treatment to be FDA approved for this condition, and it marks the first mesothelioma approval to take place in the past 16 years. The approval was based on efficacy data from the open-label phase 3 CHECKMATE 743 trial (NCT02899299), ...