FDA Green Lights Expanded Access to Pancreatic Cancer Drug, Daraxonrasib

Follow Drugslib on

By Andria Park Huynh HealthDay Reporter

Medically reviewed by Carmen Pope, Senior Medical Editor, B. Pharm. Last updated on May 4, 2026.

via HealthDay

MONDAY, May 4, 2026 — The U.S. Food and Drug Administration (FDA) granted expanded access for the use of an experimental pancreatic cancer drug, daraxonrasib.

This means the drug will be available for early access to those who previously received conventional treatment for metastatic pancreatic ductal adenocarcinoma (PDAC). A healthcare provider must request access to the medication for their patient, according to an FDA statement.

PDAC is an extremely aggressive form of pancreatic cancer with a five-year survival rate of only 3% for most patients.

The FDA received the expanded access request from the drug’s manufacturer, Revolution Medicines, on April 28 and signed it April 30.

“Granting the request two days after receiving the expanded access application reflects the FDA’s strong commitment to facilitate early access to therapies for serious and life-threatening conditions, including pancreatic cancer,” said FDA Commissioner Dr. Marty Makary.

In trials, daraxonrasib was shown to double the average survival time for pancreatic cancer patients receiving conventional treatments, according to The Washington Post.

Patients in one trial had a median survival time of a little over 13 months (meaning half lived longer, half for a shorter time), compared to roughly six months on chemotherapy.

The FDA has marked the drug’s approval as the highest priority, and it could even come sometime next year, according to The Post.

“Revolution Medicines is moving as quickly as possible to ensure safe and equitable access to daraxonrasib for eligible patients in the United States,” the company said in a statement Friday.

SOURCES: U.S. Food and Drug Administration, news release, May 1, 2026; The Washington Post, May 1, 2026

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

Source: HealthDay

Posted : 2026-05-05 02:23

Read more

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Popular Keywords