January 2024 Brief

The FDA did not fully approve sotorasib for the treatment of patients with KRAS G12C-mutated non–small cell lung cancer.

The completion of the phase 1 trial is a crucial step toward making DOC1021 available to all patients with glioblastoma multiforme.

The investigational new drug application of lacutamab, a novel drug for advanced T-cell lymphoma, was put on partial clinical hold after the death of a patient last year.

Following a patient death in the phase 2 IOV-LUN-202 trial, the FDA has issued a clinical hold.

Rinatabart sesutecan is an antibody drug conjugate that has now received a fast track designation from the FDA for the treatment of FRα-expressing ovarian cancer.

A Safe to Proceed letter from the FDA has been granted to the investigational new drug application of a phase 2 study evaluating ropidoxuridine plus radiotherapy in patients with newly diagnosed IDH-wildtype glioblastoma.

The FDA has issued a complete response letter to the biologics license application of zolbetuximab for patients with advanced, HER2-negative, claudin 18.2-positive gastric or gastoesophageal junction adenocarcinoma.

NUV-1511, a novel drug candidate for the treatment of solid tumors, has received clearance from the FDA for its investigational new drug application.

The supplemental biologics license application approval is based on findings from the phase 3 innovaTV 301 trial investigating tisotumab vedotin vs investigator’s choice of chemotherapy in cervical cancer.

With an investigational new drug application cleared by the FDA, a multi-center, open-label, modified dose-escalation, phase 1b trial of ACT-IOP-003 will begin in pancreatic cancer.

The FDA has approved the new drug application of a ready-to-dilute formulation of a treatment for breast and ovary adenocarcinoma.

The FDA completed an advice meeting with the manufacturer of olaptesed pegol in anticipation of the filing of an investigational new drug application in Q1 of 2024.

The novel CDK9 inhibitor previously received orphan drug designations in relapsed/refractory acute myeloid leukemia and peripheral T-cell lymphoma.

RC88 is a mesothelin-targeting antibody-drug conjugate that offers a novel approach to treating platinum-resistant ovarian, fallopian tube, and peritoneal cancers.

Positive findings from the KEYNOTE-A18 trial support the approval of pembrolizumab, radiotherapy, and concurrent chemotherapy in patients with high-risk locally advanced cervical cancer.

The DermaSensor device is a noninvasive tool that can diagnose skin cancer, including the 3 most common types, right at the point of testing.

Following clearance from the FDA, Hoth Therapeutics is carrying out a clinical trial as part of its open investigational new drug program for HT-001 in cancers undergoing toxicities from EGFR inhibition.

The tumor treating fields device has been given premarket approval in combination with standard therapies for the treatment of platinum-resistant non–small cell lung cancer.

The combination of avutometinib and sotorasib received FDA fast track designation for the treatment of KRAS G12C-mutant non–small cell lung cancer.

The FDA has approved erdafitinib for the treatment of locally advanced or metastatic urothelial carcinoma with FGFR3 alterations.

PTX-252, a novel molecular drug, has received an FDA orphan drug designation for the treatment of patients with acute myeloid leukemia.

NK010 represents a promising advancement in the landscape of natural killer cell-based immunotherapy across a variety of cancer types.

The FDA has accepted the biologics license application for obecabtagene autoleucel for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.

An investigational new drug for BSI-082 has been cleared by the FDA for the treatment of hematologic and solid tumors.

The FDA has approved the investigational new drug application for HBM9027, a bispecific antibody.

If approved, trastuzumab deruxtecan would be the first HER2-directed antibody-drug conjugate for a tumor-agnostic indication.

The investigational new drug application for OriCAR-017 has been cleared by the FDA for the treatment of patients with relapsed/refractory multiple myeloma.

The FDA and Japan’s Ministry of Health, Labor, and Welfare advanced lisocabtagene maraleucel for relapsed/refractory follicular and mantle cell lymphomas.

The axicabtagene ciloleucel manufacturing process has received FDA approval for a change to reduce the median turnaround time.

The application is based on promising findings from the phase 3 PERSEUS trial which were presented at the American Society of Hematology Annual Meeting in December 2023.