Feb. 16, 2024, is a landmark date in the history of immuno-oncology.
Energy and Commerce Committee Health Subcommittee Ranking Member Rep. Anna G. Eshoo (D-CA), Ranking Member Rep. Frank Pallone, Jr. (D-NJ), and Oversight and Investigations Subcommittee Ranking Member Rep. Kathy Castor (D-FL) wrote to FDA Commissioner Robert M. Califf to urge the agency to move forward with guidance to improve the diversity of populations represented in clinical trials.
FDA approved Tagrisso (osimertinib) with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
FDA has accepted for Priority Review the biologics license application for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma that has progressed after at least three prior therapies.Â
The FDA Oncology Center of Excellence published its 2023 annual report.Â
FDA has approved Onivyde (irinotecan liposome) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.
FDA has accepted the supplemental New Drug Application for Augtyro (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity.Â
FDA accepted the supplemental Biologics Application for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage 2A to 3B non-small cell lung cancer. FDA assigned a Prescription Drug User Fee Act goal date of Oct. 8.
FDA has directed the sponsors of CAR T-cell therapies to place boxed warnings on their products to indicate that the agents may cause secondary T-cell malignancies.Â
The story of Janet Woodcock’s illustrious career is not just one of professional achievements; it’s a tale of enduring partnerships, empathetic leadership, and unwavering commitment to science and patient care that will continue as she leaves public service this year.Â
