Decoding 5 Recent Regulatory and Development Steps for Sotorasib

 Amgen CEO Bob Bradway hailed progress by the biopharmaceutical industry against COVID-19
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To the uninitiated, the terminology associated with the drug development process may seem confusing — especially because not every investigational medicine takes the same path or the same amount of time.

To serve patients with hard-to-treat cancers or other serious illnesses, regulatory agencies like U.S. Food and Drug Administration (FDA) have established programs that help expedite development and review processes for certain drugs.

The path taken by sotorasib (also known as AMG 510), a KRASG12C inhibitor currently under investigation as a therapy for advanced solid tumors with KRAS G12C mutation, has so far been among the fastest of any Amgen investigational medicine. To help decipher five of the latest regulatory and development steps for sotorasib, here’s a lay person’s explanation of what each step has meant for the advancement of this innovative molecule.

1. Submitting a NDA for regulatory review

A New Drug Application (NDA) is a formal request for FDA regulators to decide whether an investigational drug can be approved as a medicine in the U.S. On December 16, 2020, Amgen submitted a NDA to the FDA, seeking approval of sotorasib for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. This is the most recent step Amgen has taken in sotorasib’s development. Amgen also plans to submit a formal request to the European Medicines Agency (EMA) by the end of 2020.

2. Real-Time Oncology Review

The FDA’s Real-Time Oncology Review (RTOR) pilot program aims to create a more efficient review process that ensures treatments are made available to patients as early as possible. The FDA Oncology Center of Excellence launched RTOR in 2018 to allow sponsors to submit clinical data supporting the NDA as they become available, rather than waiting for the full NDA. This effort is a testament to the importance that regulators have placed on advancing innovations for cancer patients. Sotorasib is currently being reviewed under the RTOR program.

3. Breakthrough Therapy designation

Breakthrough Therapy designation was established by the FDA in 2012 to expedite the development and review process for some investigational medicines. According to the FDA, programs that receive this designation are eligible for intensive guidance on an efficient drug development program, along with organizational commitments involving senior managers.1 On December 7, 2020, the FDA granted Breakthrough Therapy designation for sotorasib for locally advanced or metastatic NSCLC with KRAS G12C mutation who have received at least one prior therapy.

4. Fast Track designation

An investigational drug that receives Fast Track designation from the FDA may become eligible for more frequent meetings and written communications with FDA regulators. The medicine may also become eligible for Accelerated Approval and Priority Review, as well as Rolling Review, which allows sections of the NDA to be submitted and reviewed as they are completed, rather than waiting until all sections are complete to start the review process.2 Sotorasib (also called AMG 510) received the FDA’s Fast Track designation in August 2019.

5. Amgen’s R&D record for cycle time

Recent changes to Amgen’s R&D strategy put a priority on rapidly advancing the company’s most encouraging molecules. Sotorasib moved from first-in-human dosing to first regulatory submission in about 30 months — a cycle time significantly faster than any other investigational drug in Amgen’s 40-year history.


Whether it's vaccines for the COVID-19 pandemic or innovative cancer therapies, the FDA has demonstrated a powerful commitment to accelerating the development and review of medicines intended for patients with significant unmet needs. “We would like to thank regulators at the FDA for their tireless efforts and focus during this incredibly challenging time,” said Dr. Steven Galson, Amgen’s senior vice president of Global Regulatory Affairs and Strategy.


  1. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
  2. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

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