Tag Archive for: Lumakras

Frontier Medicines on Thursday closed its oversubscribed $80 million Series C funding round,  which it will use to advance its potentially first-in-class next-generation KRAS blocker FMC-376.

Amgen announced that the U.S. Food and Drug Administration (FDA) has completed its review of the company’s supplemental New Drug Application seeking full approval of LUMAKRAS® (sotorasib).

While Amgen and Mirati are widely viewed as frontrunners to win the first front line approval, analysts—and competitors—say the field is still wide open.

Mirati Therapeutics said on Friday the European medicines regulator’s panel has recommended approval of its treatment for a type of lung cancer.

Sanofi appears to be considering a buyout of cancer drugmaker Mirati Therapeutics, according to Bloomberg reporting on Thursday, citing sources familiar with the matter.

Amgen’s regulatory ambitions for its non-small cell lung cancer drug Lumakras (sotorasib) ran into headwinds Tuesday, after FDA staff indicated in their briefing document that there might not be sufficient evidence of its efficacy to justify full approval.

The U.S. Food and Drug Administration’s staff reviewers said on Tuesday that Amgen’s late-stage study may not provide enough evidence of effectiveness for its lung cancer drug, as the company pursues a traditional approval for the treatment.

Eli Lilly presented the first clinical data on its KRAS G12 inhibitor at the American Association for Cancer Research (AACR) meeting in Orlando on Monday. Lilly investigators said they hoped to differentiate their Phase I candidate from the competitive KRAS space by making it the first to gain approval as a first-line treatment.

Mirati gets the green light from the FDA for its KRAS G12C-mutated lung cancer medication.

Early trial data shows that a combination of Mirati Therapeutics experimental drug adagrasib and Merck & Co.’s immunotherapy Keytruda helped about half of previously untreated metastatic lung cancer patients, with manageable side effects, Mirati said on Monday.