AstraZeneca/Daiichi's Flagship Drug Enhertu Secures Accelerated FDA Approval For Pretreated Cancer Patients With Solid Tumor

On Friday, the FDA approved Daiichi Sankyo Ltd’s DSKYF DSNKY and AstraZeneca Plc’s AZN Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. 

This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Also Read: New Hope for Aggressive Lung Cancer: AstraZeneca’s Imfinzi Shows Promising Results in Phase 3 Trial.

The first tumor agnostic approval of a HER2-directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including DESTINY-PanTumor02, DESTINY-Lung01 or DESTINY-CRC02. 

In DESTINY-PanTumor02, the confirmed objective response rate (ORR) was 51.4%, and the median duration of response (DOR) range was 19.4 months. 

In DESTINY-Lung01, a confirmed ORR of 52.9% and a median DOR range of 6.9 months were seen. 

In DESTINY-CRC02, a confirmed ORR was 46.9%, and the median DOR range was 5.5 months.

ENHERTU is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and Embryo-Fetal toxicity. 

“This fifth indication in the U.S. is a significant milestone as eligible patients with previously treated metastatic HER2 positive solid tumors may now be treated with ENHERTU,” said Ken Keller, Global Head of Oncology Business and President and CEO of Daiichi Sankyo, Inc. “The accelerated approval by the FDA for this tumor agnostic indication is based on the clinically meaningful efficacy seen with ENHERTU across numerous types of metastatic cancers.”

Price Action: AZN shares are up 0.01% at $67.46 on the last check Monday.

Photo via Wikimedia Commons