logo
Plus   Neg
Share
Email

Enhertu Granted BTD In US For HER2-mutant Metastatic Non-small Cell Lung Cancer

AstraZeneca Plc. (AZN.L,AZN) said that and Daiichi Sankyo Co.'s (DSKYF.PK) Enhertu has been granted Breakthrough Therapy Designation in the US for the treatment of patients with metastatic non-small cell lung cancer or NSCLC whose tumours have a HER2 mutation and with disease progression on or after platinum-based therapy.

NSCLC is the most common type of lung cancer, and prognosis is particularly poor for patients with metastatic disease as only about 6-10% will be alive five years after diagnosis. Approximately 2-4% of patients with NSCLC have a HER2 mutation.

The Food and Drug Administration's Breakthrough Therapy Designation is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need.

The overall safety and tolerability profile of Enhertu in the ongoing DESTINY-Lung01 trial is consistent with that seen in the Phase I trial. The most common adverse events to date are gastrointestinal and haematological including nausea, alopecia, anaemia, decreased appetite and decreased neutrophil count.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Hyundai Motor has launched a new IONIQ brand dedicated to battery electric vehicles, as the automaker is accelerating its efforts to gain a share in the fast-growing global EV market. Under the IONIQ brand, Hyundai plans to introduce three new dedicated electric vehicle models over the next four years. Hyundai is South Korea's largest automaker. Amazon.com, Inc. is in talks with mall operator Simon Property Group, Inc. to use the abandoned anchor departmental stores of JC Penny and Sears at their malls as fulfillment centers, reports said. This is expected to help the e-commerce giant in boosting their last mile delivery, which is the last leg of the delivery process. The U.S. Food and Drug Administration announced the approval of Trevena Inc.'s Olinvyk (oliceridine), a new opioid for intravenous use in hospitals or other controlled clinical settings. Olinvyk is an opioid agonist to manage moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate.
Follow RTT