FDA News

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.

The resubmission of the biologics license application for cosibelimab for locally advanced or metastatic cutaneous squamous cell carcinoma follows a complete response letter from the FDA in December 2023.

The updated risk evaluation and mitigation strategies for autologous CAR T-cell therapy removed requirements for training and educational materials about the risk for certain toxicities.

Throughout June, the FDA approved drugs for the treatment of diseases including myelodysplastic syndrome, thyroid cancer, endometrial cancer, colorectal cancer, and follicular lymphoma.

Monotherapy with IBI343 received fast track designation from the FDA for advanced unresectable or metastatic pancreatic ductal adenocarcinoma.

An sBLA was granted priority review from the FDA, which is seeking the approval of pembrolizumab plus chemotherapy for the frontline treatment of malignant pleural mesothelioma.

The ready-to-dilute formulation of Tepylute for breast and ovarian cancers can help to reduce prep time and provide more accurate dosing.

An accelerated approval has been granted by the FDA to epcoritamab-bysp (Epkinly) for adult patients with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy.

Accelerated approval has been granted to adagrasib for use with cetuximab in previously treated adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer.

The biologics license application for subcutaneous amivantamab is seeking approval for the treatment of EGFR-positive non-small cell lung cancer.

The approval of this pembro-chemo combination for adults with primary advanced or recurrent endometrial carcinoma includes those with mismatch repair-proficient or -deficient disease.

The FDA approved blinatumomab for patients 1 month or older with CD19-positive, Philadelphia chromosome–negative, B-cell precursor acute lymphoblastic leukemia.