Eli Lilly Cancer Drug Wins FDA Breakthrough Therapy Status

The US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Eli Lilly and Company's (NYSE:LLY) experimental drug olomorasib as a standalone treatment for patients with advanced pancreatic cancer and a KRAS G12C mutation who have received at least one systemic therapy.

Physicians diagnose pancreatic cancer in approximately 60,000 people in the US annually, according to the release, resulting in an estimated 50,000 deaths each year. Patients with metastatic cancer face a five-year survival rate of below 5 percent.

While KRAS mutations drive about 90 percent of pancreatic cancers, the specific KRAS G12C mutation is found in just 1 to 2 percent of cases, and the market currently lacks approved therapies that specifically target this mutation.

"Pancreatic cancer has historically been one of the most difficult-to-treat cancers and people whose tumors harbor a KRAS G12C mutation face limited options once their disease progresses," Jacob Van Naarden, executive vice president and president of Lilly Oncology, said in the company’s recent press release.

"This Breakthrough Therapy designation reflects the early potential we're seeing with olomorasib in this setting and the critical need for new treatment options."

The FDA based the designation on preliminary results from the Phase 1/2 LOXO-RAS-20001 trial. Olomorasib previously received the same expedited regulatory designation for its use in combination with Merck & Company's (NYSE:MRK) immunotherapy Keytruda to treat patients with mutated non-small cell lung cancer.

Lilly continues to expand its clinical pipeline, funding external acquisitions with cash generated by its GLP-1 weight-loss and diabetes franchise. The major pharmaceutical company has committed more than US$10 billion upfront across eight deals this year.

In its most recent transaction, Lilly agreed in mid-July to buy clinical-stage developer AtaiBeckley (NASDAQ:ATAI) for a US$2.8 billion upfront cash payment, establishing a foothold in the experimental psychedelic drug market.

The acquisition gives Lilly control of BPL-003, a clinic-administered nasal spray derived from dimethyltryptamine (DMT). The compound is currently in Phase 3 clinical trials for treatment-resistant depression, with initial results expected in 2029.

Clinical researchers are testing whether psychedelics can rapidly force neurons to forge new connections, reversing plasticity deficits in patients with depression.

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Securities Disclosure: I, Giann Liguid, hold no direct investment interest in any company mentioned in this article.