FDA News

The FDA accepted a resubmission of a new drug application for frontline rivoceranib plus camrelizumab to treat unresectable, metastatic HCC.

The FDA approved neoadjuvant nivolumab plus chemo, followed by adjuvant nivolumab for non-small cell lung cancer without EGFR mutations or ALK rearrangements.

ODAC voted against the use of PD-L1 expression as a predictive biomarker in gastric cancers.

The agency approved selpercatinib for the treatment of patients with advanced or metastatic, RET-mutant medullary thyroid cancer.

The FDA approved osimertinib for locally advanced, unresectable stage III EGFR-mutated non-small cell lung cancer.

The FDA approved isatuximab plus bortezomib, lenalidomide, and dexamethasone for patients with newly diagnosed myeloma who are ineligible for ASCT.

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.

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.

Fast track designation has been granted by the FDA to Deltacel with low-dose radiation for pretreated metastatic non–small cell lung cancer.

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.