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.