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Amgen aims for first KRAS inhibitor approval in the US

Sotorasib is a potential treatment for advanced KRAS G12C-mutated NSCLC

Amgen is aiming for the first approval of a KRAS targeting drug after announcing that it has filed its investigational drug sotorasib with the US Food and Drug Administration (FDA).

The company has filed a new drug application (NDA) with the FDA for the investigational KRAS inhibitor, seeking approval for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received at least one prior systemic therapy.

If approved, it would become the first therapy designed to target the KRAS pathway, an oncogene that is implicated in around a third of all human cancers.

In NSCLC, KRAS G12C is the most common KRAS mutation, with around 13% of patients with NSCLC in the US carrying this particular mutation.

"Sotorasib was the first KRAS G12C inhibitor to enter the clinic and now is on track to potentially be the first approved targeted therapy for patients with advanced NSCLC harbouring the KRAS G12C mutation,” said David M. Reese, executive vice president of research and development at Amgen.

"This submission, along with these other important regulatory achievements, underscore Amgen's commitment to bringing this potential treatment option to patients as quickly as possible,” he added.

In October, Amgen revealed topline results from its phase 2 study of sotorasib in advanced NSCLC.

The CodeBreaK 100 study evaluated the KRAS inhibitor in 126 patients with KRAS G12C mutated advanced NSCLC patients who had failed a median of two prior lines of anti-cancer therapies, including immunotherapy and/or chemotherapy.

In the phase 2 study, sotorasib demonstrated an objective response rate consistent with previously reported phase 1 data.

Data from the phase 1 trial found that seven (53%) of 13 experienced NSCLC patients with the KRAS G12C mutation experienced a partial response at a dose of 960 mg, considered to be the most effective, with the remaining six (46%) all having stable disease.

Amgen is due to submit the detailed results from the phase 2 study to the International Association for the Study of Lung Cancer World Conference on Lung Cancer, scheduled to take place in January 2021.

The NDA for sotorasib is being reviewed under the FDA’s real-time oncology review (RTOR) pilot programme, which seeks to more efficiently review potential oncology treatments with the aim of making them available to patients as early as possible.

Article by
Lucy Parsons

18th December 2020

From: Regulatory



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