September 2023 Brief

INT230-6 is an investigational product candidate made up of cisplatin, vinblastine, and a penetration enhancer molecule being evaluated for patients with soft tissue sarcoma.

Guidance from the FDA has provided a clear pathway and requested no additional efficacy or safety trials for the resubmission of the biologics license application for denileukin diftitox in cutaneous T-cell lymphoma.

On the heels of positive results from GENESIS, a phase 3 study, the FDA has approved the first stem cell mobilization therapy for multiple myeloma.

Preclinical data of soquelitinib has demonstrated tumor responses in difficult to treat T-cell malignancies. The agent will now be evaluated in a phase 3 study in relapsed peripheral T cell lymphoma.

The combination of AFM13 with AlloNK has been granted FDA fast track designation and is being investigated in the phase 2 LuminICE-203 study for patients with Hodgkin lymphoma.

Data from the phase 2 FIREFLY-1 trial support the new drug application for tovorafenib in relapsed or progressive pediatric low-grade glioma. The regulatory agency anticipates filing the application by mid-November 2023

A phase 1/2 study of tulmimetostat in patients with advanced solid tumors and lymphomas is underway.

A new target action date has been set as the FDA continues to consider approving lifileucel for the treatment of advanced melanoma.

Momelotinib has emerged as a new FDA-approved treatment option for patients with myelofibrosis and anemia.

HEMO-CAR-T is an autologous chimeric antigen receptor T-cell therapy being developed against an acute myeloid leukemia target.

A speedy review of an approval application for belzutifan has been undertaken by the FDA.

A supplemental biologics license application seeking the approval of pembrolizumab, external beam radiotherapy, and concurrent chemotherapy, followed by brachytherapy has been accepted for priority review by the FDA for advanced cervical cancer.

NXC-201, a next-generation chimeric antigen receptor T-cell therapy, has potential to expand as treatment for patients with amyloid light chain amyloidosis.

Responses from the FDA regarding questions submitted for a Type B pre-investigational new drug application meeting have provided a pathway for the start of a phase 2 trial of ropidoxuridine in glioblastoma.

A phase 2 study, PUMA-ALI-4201, will further investigate alisertib for the treatment of small cell lung cancer.

The FDA has issued a complete response letter for the biologics license application seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, but has not requested additional findings or clinical trials.

Findings from a phase 1 support the fast track designation given by the FDA to IDE161, a potent, selective, small-molecule inhibitor of PARG, for patients with BRCA1/2 mutant ovarian cancer.

The investigational antibody-drug conjugate, MYTX-011, is one step further in development for the treatment of non–small cel lung cancer with cMET overexpression.

ABM-1310 is an investigational small molecule BRAF inhibitor that is being development for the treatment of various BRAF V600E-mutant solid tumors.

Bosutinib has a new indication in leukemia as a well as a newly-approved formulation.

IDE161 now has 2 fast track designations from the FDA for patients with breast cancer and ovarian cancer. The agent continues to be evaluated in a first-in-human, phase 1 study for patients with advanced solid tumors.

Priority review to the biologics license application for odronextamab has been granted by the FDA for adult patients with follicular lymphoma and diffuse large B-cell lymphoma.

Here is a lookback at all of the FDA happenings from September 2023.