February 2024 Brief

The FDA granted a fast track designation to BST02 for patients with all forms of liver cancer.

The FDA’s Oncologic Drug Advisory Committee will be held on March 15, 2024, to review data pertaining to the supplemental biologics license application of ide-cel in relapsed or refractory multiple myeloma.

A fast track designation to UV1 combination therapy for malignant mesothelioma from the FDA signifies expedited review and development for a promising treatment option, offering hope for patients with malignant pleural mesothelioma.

The allogeneic gamma delta 2 T-cell therapy ACE2016 will undergo investigation in a phase 1 trial for the treatment of patients with locally advanced or metastatic EGFR-expressing solid tumors.

If approved, vepdegestrant could provide a valuable new treatment option for patients with ER+/HER2- breast cancer who have progressed after receiving endocrine therapy.

Along with the FDA, the European Medicines Agency has also accepted the application of nivolumab and chemotherapy in operable non–small cell lung cancer.

Magrolimab will no longer be in development as a treatment option for patients with hematologic malignancies.

The FDA has accepted Xspray Pharma's resubmitted application for Dasynoc, a potential new treatment for chronic myeloid leukemia and acute lymphoblastic leukemia.

212PB-DOTAMTATE is the first targeted alpha therapy to receive a breakthrough therapy designation in this intent-to-treat population.

The phase 1 study of HEMO-CAR-T in patients with acute myeloid leukemia can proceed following the lifted clinical hold.

There are currently no FDA-approved agents for relapsed peripheral T-cell lymphoma, and soquelitinib has the potential to fill an unmet need.

The FDA has granted fast track designation to BXCL701 with an immune checkpoint inhibitor for metastatic small cell neuroendocrine prostate cancer resistant to chemotherapy and showing no evidence of microsatellite instability.

Liposomal irinotecan with 5-fluorouracil, leucovorin, and oxaliplatin (NALIRIFOX) is now an FDA-approved treatment option for patients with metastatic pancreatic ductal adenocarcinoma.

The FDA has granted the supplemental new drug application of repotrectinib priority review.

The biologics license application for denileukin diftitox has been resubmitted to the FDA for the treatment of cutaneous T-cell lymphoma after at least 1 prior systemic therapy.

The FDA has now fully approved tepotinib for the treatment of metastatic non-small cell lung cancer.

The FDA has granted an orphan drug designation to tigilanol tiglate for the treatment of soft tissue sarcoma.

Following the FDA clearance of an investigational new drug application, a phase 1 trial will evaluate KME-0584 for the treatment of patients with acute myeloid leukemia and myelodysplastic syndrome.

The FDA has approved lifileucel, a tumor infiltrating lymphocyte therapy, for the treatment of advanced melanoma.

The FDA has approved the combination of osimertinib plus chemotherapy for the treatment of EGFR-mutated non-small cell lung cancer.

The FDA has accepted the biologics license application of datopotamab deruxtecan for the treatment of nonsquamous non-small cell lung cancer.

The FDA has accepted and granted priority review for the new drug application for vorasidenib for the treatment of IDH-mutant diffuse glioma, with a PDUFA action date set for August 20, 2024.

Pembrolizumab shows promise in advanced endometrial cancer, cutting progression risk by up to 70%. The FDA has granted a priority review for this treatment option.

Adagrasib plus cetuximab as a potential treatment option addresses an unmet need in pretreated KRAS G12C-mutated colorectal cancer, offering hope for improved outcomes.

The reduced dosing frequency of 1.5 mg/kg every 2 weeks for teclistamab in relapsed/refractory multiple myeloma who have sustained a complete response or better for at least 6 months provides flexibility in dosing schedules for patients.

IMM-1-104 has gained a fast track designation from the FDA for the treatment of patients with pancreatic ductal adenocarcinoma who have progressed after 1 line of treatment.

Linvoseltamab shows promise for patients with heavily pretreated multiple myeloma, achieving a 71% overall response rate in a phase 1/2 trial.

An orphan drug designation has been granted by the FDA for IO-202 as a treatment option for patients with chronic myelomonocytic leukemia.

The FDA has granted an investigational new drug application to the investigational chimeric antigen receptor T-cell therapy IMC001 for the treatment of EpCAM-positive advanced gastrointestinal tumors.

The FDA has accepted the biologics license application of tislelizumab in combination with chemotherapy for the treatment of locally advanced or metastatic gastric or gastroesophageal cancers.

If FDA-approved, epcoritamab would be the first and only subcutaneous bispecific antibody indicated for the treatment of adult patients with relapsed/refractory follicular lymphoma after 2 rounds of previous therapy.

The FDA has granted a breakthrough therapy designation to BAY 2927088 for the treatment of non-small cell lung cancer harboring HER2-activating mutations.

Approval for melphalan flufenamide has been withdrawn by the FDA due to the failure of its confirmatory trial to demonstrate its clinical benefit and the lack of evidence supporting its safety and effectiveness.

A fast track designation has been granted to 9MW2821 by the FDA for patients with advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

The natural killer cell therapy IDP-023 is being studied in a phase 1 trial for the treatment of patients with non-Hodgkin lymphoma and multiple myeloma.

Here’s a look back on all the FDA happenings from the month of February 2024.