Dive Brief:

• Amgen is moving closer to submitting its closely watched cancer drug sotorasib for U.S. approval, announcing on Tuesday it had secured two regulatory designations from the Food and Drug Administration that could speed the agency’s review.

• The FDA will include sotorasib in its Real-Time Oncology Review program, which allows agency drug evaluators to begin assessing study results and analyses even before a formal request for approval has been submitted. Amgen said it has already started transferring data to the FDA under the initiative.

• The biotech expects to file its full application for sotorasib by the end of the year, according to a Dec. 8 statement. The three drugs previously reviewed under the real-time program won FDA approval about three months ahead of schedule, suggesting sotorasib may be cleared by mid-2021, Piper Sandler analyst Christopher Raymond wrote in a note to investors.

Dive Insight:

Sotorasib is the crown jewel in Amgen’s research pipeline and represents a step forward in cancer research after four decades of scientists trying unsuccessfully to target tumour-fueling mutations in a gene called KRAS. The gene is often altered in lung, colon and pancreatic cancers.

Sotorasib binds to KRAS proteins produced by one such mutation, called G12C. The drug’s first target is in non-small cell lung cancer. Amgen is seeking approval for patients with locally advanced or metastatic tumours who have already received at least one systemic therapy and test positive for the mutation.

KRAS G12C mutations are found in the tumours of an estimated 25,000 newly diagnosed non-small cell lung cancer patients each year, Amgen said.

Results from an early-stage study showed sotorasib shrank tumours in about a third of patients, about twice as many as would be expected with chemotherapy. Among the study participants, median progression-free survival was about six months, an improvement over other treatment options but still only a modest benefit.

More recently, Amgen said a Phase 2 trial showed similar efficacy, but data have not yet been released.

The drugmaker is testing sotorasib in combination with other drugs and in a dozen tumour types, part of a broad clinical program that’s delivered data in more than 600 patients to date.

Sotorasib has company, however, as a wave of new KRAS-blocking drugs advances through or into clinical testing. Mirati Therapeutics, Johnson & Johnson and Boehringer Ingelheim are among the other companies working on ways to target cancers driven to growth by KRAS mutations.

Analysts expect sotorasib and its rivals to earn significant revenue, should they be proven in testing and approved. Piper Sandler’s Raymond, for instance, predicts sotorasib sales may reach close to $1.4 billion within five years.