Mirati Therapeutics, Inc. is one step closer to seeing its first oncology drug approved for prescribed use.
On Feb. 15 the company announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for adagrasib – a pill for the treatment of patients with KRASG12C-mutated non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy.
The FDA set the drug’s Prescription Drug User Fee Action (PDUFA) date for Dec. 14 of this year.
“The acceptance of our NDA for adagrasib is a significant step forward in Mirati’s ongoing efforts to advance innovative, differentiated treatment options for patients with KRAS-G12C cancers,” said Charles Baum, M.D., Ph.D., president, founder and head of research and development at Mirati. “We look forward to working with the FDA during their review of our application and potentially provide a novel option for patients with non-small cell lung cancer.”
Adagrasib works by inhibiting the KRAS-G12C mutation that cause large tumors to grow in the lungs. 85% of all lung cancers are non-small cell. The KRAS G12C mutation accounts for 50% of all KRAS mutations in NSCLC, with approximately 14% of patients with NSCLC harboring a KRAS G12C mutation.
The NDA is based on the Phase 2 registration-enabling cohort of the KRYSTAL-1 study of adagrasib in patients with advanced NSCLC harboring the KRAS-G12C mutation following prior treatment with immunotherapy and chemotherapy, either together or sequentially.
Mirati reported positive topline data from this cohort in September 2021 showing adagrasib had an objective response rate of 43% and a disease control rate of 80% based on a central independent review. Mirati plans to present detailed results of the study at a medical conference during the first half of 2022.
“KRAS mutations have been notoriously hard to target and historically have had limited therapeutic options. The KRAS-G12C biomarker in particular is associated with poor survival outcomes,” said Pasi A. Jänne, M.D., Ph.D., an investigator participating in the KRYSTAL-1 study, and director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute.
“The FDA’s review of the adagrasib NDA marks important progress toward potentially providing a new, targeted option for those living with KRAS-G12C-mutated non-small cell lung cancer,” Jänne added.
Milestones for Mirati
The NDA announcement is a milestone for Mirati — the first new drug application from the company that the FDA has accepted.
In addition to accepting the NDA, adagrasib has been given a breakthrough therapy designation, enabling Mirati to address FDA questions while their review is ongoing.
If all goes well, Mirati will be able to officially launch adagrasib at the end of this year.
In addition to adagrasib, the company is also rapidly advancing its broader portfolio, which includes sitravatinib, a spectrum-selective kinase inhibitor that inhibits receptor tyrosine kinases; and MRTX1719, an MTA cooperative PRTM5 inhibitor.
The company also aims to advance two additional programs into the clinic in the next year – MRTX1133, a KRASG12D inhibitor and MRTX0902, the company’s SOS1 inhibitor.
CEO: David Meek
Headquarters: San Diego
Business: Oncology therapies
Funding: $475 million raised
Stock: (NASDAQ) MRTX
Notable: Mirati loosely translated means “targeted” in Italian