FDA News

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.

The FDA approved durvalumab plus carboplatin and paclitaxel, followed by single-agent durvalumab for primary advanced or recurrent dMMR endometrial cancer.

The FDA granted accelerated approval to repotrectinib to treat adult and pediatric patients with NTRK gene fusion-positive solid tumors.

This traditional approval updates the accelerated approval that selpercatinib received in 2020 for this indication in patients 12 years and older.

The priority review granted by the FDA to the supplemental new drug application for osimertinib is seeking approval for its treatment of stage III non-small cell lung cancer with EGFR mutations.

The FDA granted an approval to imetelstat for certain patients with low- to intermediate-1-risk MDS who have transfusion-dependent anemia.

This marks the only CAR T-cell therapy approved by the FDA for 4 subtypes of non-Hodgkin lymphoma.

Selpercatinib was granted accelerated approval from the FDA for patients aged 2 years and older with thyroid cancer or solid tumors with RET mutations.

A breakthrough device designation has been granted by the FDA to Teal Wand, an at-home screening test for cervical cancer.

The accelerated approval of infigratinib has been withdrawn by the FDA for previously treated, FGFR2-positive, advanced cholangiocarcinoma.