A Look Back at FDA News in the Month of February

New indications were approved by the FDA within the last month, including abemaciclib for HER2-negative breast cancer, durvalumab for non–small cell lung cancer, and abiraterone acetate for castration-sensitive prostate cancer.

Frontline Abemaciclib Granted FDA Approval for HR+/HER2- Breast Cancer

Based on data from the phase III MONARCH 3 trial, abemaciclib, a CDK4/6 inhibitor, was approved by the FDA on February 26 for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.

Durvalumab Granted FDA Approval for Locally Advanced NSCLC

On February 16, durvalumab was granted approval by the FDA for the treatment of patients with locally advanced, unresectable stage III NSCLC who have not progressed following chemoradiotherapy. This approval was based on results from the phase III PACIFIC trial.

Ivosidenib Granted Priority Review Designation by FDA for IDH1+ AML

A priority review designation was granted to isvosidenib (AG-120) by the FDA for the treatment of patients with relapsed/refractoryIDH1-mutant acute myeloid leukemia. Agios Pharmaceuticals, the company developing the targeted therapy, released a statement announcing the designation on February 15.

Apalutamide Receives FDA Approval for Nonmetastatic Castration-Resistant Prostate Cancer

Apalutamide (Erleada) was the first treatment to be approved by the FDA for patients with CRPC on February 14. This approval was based on findings from the phase III SPARTAN trial.

Lorlatinib Granted Priority Review by FDA for ALK+ NSCLC

A new drug application for lorlatinib for use in patients withALK-positive metastatic NSCLC who have progressed on 1 or more ALK tyrosine kinases inhibitors has been granted a priority review designation by the FDA. The priority review follows a Breakthrough Therapy designation awarded to the ALK inhibitor in April 2017.

Abiraterone Approved by FDA for CSPC

Findings from the phase III LATITUDE trial led to the FDA approval of abiraterone acetate (Zytiga) in combination with prednisone for men with high-risk castration-sensitive prostate cancer. The approval was announced on February 8 by Janssen Biotech, the developer of the antiandrogen therapy.

Duvelisib Submitted for FDA Approval in CLL, Follicular Lymphoma