FDA News

The FDA approved amivantamab-vmjw plus chemotherapy for locally advanced or metastatic non–small cell lung cancer (NSCLC) that harbors EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR TKI.

The FDA approved pembrolizumab plus pemetrexted and platinum chemotherapy for advanced or metastatic malignant pleural mesothelioma.

The Food and Drug Administration approved ribociclib plus an aromatase inhibitor for hormone receptor (HR)–positive, HER2-negative stage II and III early breast cancer that has a high risk of recurrence.

The agency approved the subcutaneous injection of atezolizumab and hyaluronidase-tqjs for all of the adult indications as the intravenous formulation of atezolizumab.

Companion diagnostics have been approved by the FDA for olaparib plus abiraterone in patients with metastatic castration-resistant prostate cancer.

The FDA approved Boruzu, a new presentation of bortezomib, for subcutaneous or intravenous administration in patients with multiple myeloma and mantle cell lymphoma.

Throughout August, the FDA approved drugs for the treatment of diseases including non-small cell lung cancer, cutaneous T-cell lymphoma, astrocytoma/oligodendroglioma, and endometrial cancer.

Breakthrough therapy designation has been granted by the FDA to GSK5764227 for potential use in some patients with extensive-stage SCLC.

A supplemental biologics license application has been accepted by the FDA for nivolumab plus ipilimumab as first-line treatment for unresectable hepatocellular carcinoma.

A CRL has been issued by the FDA to the biologics license application seeking approval of linvoseltamab to treat some patients with multiple myeloma.

First-line amivantamab plus lazertinib has been approved by the FDA for locally advanced or metastatic EGFR-mutated non–small cell lung cancer.

Neoadjuvant durvalumab plus chemotherapy, followed by adjuvant durvalumab, received approval from the FDA for select patients with resectable non–small cell lung cancer.

The FDA approved axatilimab for adults and children with chronic graft-vs-host disease whose disease progressed after 2 or more lines of systemic therapy.

The biologics license application that was resubmitted for remestemcel-L has been accepted by the FDA for the potential treatment of children with steroid-refractory acute graft-vs-host-disease.

Ozuriftamab vedotin, an ROR2-targeted antibody drug conjugate, received fast track designation from the FDA for recurrent or metastatic head and neck squamous cell carcinoma.

Denileukin diftitox received FDA approval to treat relapsed/refractory cutaneous T-cell lymphoma previously treated with at least 1 systemic therapy.

This marks the first approval of a systemic therapy for patients with grade 2 astrocytoma or oligodendroglioma with an IDH1 or IDH2 mutation.

Fast track designation has been awarded by the FDA to the next-generation precision radiopharmaceutical therapy ABD-147 to treat extensive-stage small cell lung cancer.

Accelerated approval has been granted by the FDA to afamitresgene autoleucel for certain patients with pretreated unresectable or metastatic synovial sarcoma.

A dostarlimab-gxly combination was approved for advanced or recurrent endometrial cancer.

Darzalex Faspro plus VRd was approved by the FDA for induction and consolidation in newly diagnosed multiple myeloma eligible for ASCT.

The FDA approved the Shield blood test for colorectal screening in adults aged 45 years and older with an average risk for the disease.

The TIL cell therapy OBX-115 received fast track designation from the FDA for locally advanced or metastatic melanoma.

The antibody drug conjugate BNT324/DB-1311 received fast track designation for the potential treatment of unresectable advanced or metastatic castration-resistant prostate cancer with disease progression.

The fast track status from the FDA is supported by findings from a phase 1 trial in glioblastoma, which demonstrated the overall survival benefit from DOC1021.

The FDA granted the investigational menin-MLL inhibitor DSP-5336 fast track designation for KMT2A-rearranged/NPM1-mutant acute myeloid leukemia.

The CAR T-cell therapy ADI-270 received fast track designation from the FDA for pretreated advanced clear cell renal cell carcinoma.

Alpha-emitting radiopharmaceutical Radspherin receives a fast track designation from the FDA for peritoneal carcinomatosis from ovarian cancer.