FDA News

A biologics license application has been accepted by the FDA for first-line tislelizumab plus chemotherapy for gastric/gastroesophageal junction cancer.

The FDA approved zanubrutinib plus obinutuzumab for the treatment of patients with relapsed or refractory follicular lymphoma after receiving 2 or more lines of systemic therapy.

Nivolumab plus cisplatin and gemcitabine received FDA approval for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

The antibody-drug conjugate inotuzumab ozogamicin was approved by the FDA for the treatment of patients aged 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.

An orphan drug designation has been granted by the FDA to ocifisertib as a potential treatment option in acute myeloid leukemia.

Priority review was granted by the FDA to a supplemental new drug application for adagrasib plus cetuximab for the treatment of advanced KRAS G12C–mutated colorectal cancer.

Amivantamab was approved by the FDA as first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations or as therapy for those whose disease progressed on or after platinum-based chemotherapy.

The label expansion for ibrutinib with an oral suspension formulation has been approved by the FDA in all current indications including Waldenström macroglobulinemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, and chronic graft-versus-host disease.

A supplemental Biologics License Application for teclistamab-cqyv (Tecvayli) has been approved by the FDA at a reduced dose of 1.5 mg/kg every 2 weeks for the treatment of patients with relapsed/refractory multiple myeloma who have maintained a complete response or greater for at least 6 months.

The FDA approved osimertinib for use with platinum-based chemotherapy to treat patients with locally advanced or metastatic non-small cell lung cancer that harbor EGFR exon 19 deletions or exon 21 L858R mutations.

Lifileucel is the first TIL therapy approved by the FDA for a solid tumor, specifically previously treated unresectable or metastatic melanoma.

The FDA granted an orphan drug designation to soquelitinib for potential use in T-cell lymphoma.

Tepotinib has received a traditional approval from the FDA for metastatic NSCLC with MET exon 14 skipping alterations, updating the previous accelerated approval from 2021.

Irinotecan liposome has been approved by the FDA for use with oxaliplatin, leucovorin, and fluorouracil to treat patients with metastatic pancreatic adenocarcinoma.

Fast track designation has been granted by the FDA to vepdegestrant for the treatment of select patients with ER-positive/HER2-negative locally advanced or metastatic breast cancer.

FDA granted a fast-track designation to the TROP2-directed ADC BNT325/DB-1305 for the treatment of platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cancer.

The FDA granted efineptakin alfa an orphan drug designation, deeming it a potential treatment option for pancreatic cancer.

A priority review has been granted by the FDA to trastuzumab deruxtecan for the treatment of unresectable or metastatic HER2-positive advanced solid tumors.

Erdafitinib was approved for the treatment of adults with locally advanced or metastatic urothelial carcinoma, which amends a previously approved indication of the drug.

Pembrolizumab plus chemoradiotherapy has been approved by the FDA for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer.

A supplemental biologics license application has been granted priority review by the FDA, which seeks a full approval of tisotumab vedotin for patients with recurrent or metastatic cervical cancer that progressed on or following frontline therapy.

The Food and Drug Administration approved an on-body delivery system for pegfilgrastim-cbqv, a biosimilar of pegfilgrastim.

In this special episode of The Vitals, we ring in the New Year 2024 by combing through 2023 FDA approvals.

The FDA has granted approval to enfortumab vedotin plus pembrolizumab for patients with locally advanced or metastatic urothelial cancer.

The FDA has approved belzutifan to treat patients with advanced renal cell carcinoma (RCC) who have already undergone PD-1 or PD-L1 inhibitor and a VEGF tyrosine kinase inhibitor.

Eflornithine (Iwilfin) received FDA approval to reduce the risk for relapse in pediatric and adult patients with high-risk neuroblastoma, making it the first therapy to reduce risk for relapse in children with the disease.

A priority review of nivolumab plus cisplatin-based chemotherapy as a frontline treatment option for adult patients with unresectable or metastatic urothelial carcinoma is underway.

The FDA has approved the non-covalent BTK inhibitor, pirtobrutinib, to treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have already undergone 2 lines of therapy.