April was a busy month for Thousand Oaks biotech giant Amgen Inc., with its gastroesophageal cancer drug gaining breakthrough designation status with the U.S. Food and Drug Administration, and a program launch for non-small cell lung cancer biomarker testing.The promising stomach cancer drug in Amgen’s oncology portfolio, referred to as bemarituzumab, is the second of Amgen’s cancer therapies to receive the designation. The first was its KRAS G12C inhibitor, a drug to treat non-small cell lung cancer.This type of FDA designation expedites development and regulatory review for drugs if they “demonstrate substantial improvement” compared to other drugs on the market, the company said.The therapy garnered FDA attention through a clinical trial evaluating the effectiveness of the drug in combination with chemotherapy, versus chemotherapy by itself.
“Bemarituzumab demonstrated clinically meaningful outcomes in key endpoints for patients with advanced gastric or gastroesophageal cancer as a frontline therapy,” Dr. David Reese, vice president of research and development at Amgen, said in a statement.Added Reese: “Amgen looks forward to further investigating the role of (this treatment) and will continue to work with regulatory agencies on next steps to bring this potential first-in-class, frontline therapy to patients.” More than 1 million new gastric cancer cases are diagnosed annually, Amgen said. The disease is “particularly prevalent” in Asia, where Amgen seeks to expand its global footprint, according to previous earnings calls.Biomarker programAmgen’s Biomarker Assist program aims to connect more non-small cell lung cancer patients with biomarker testing, a “critical first step” for ensuring the right cancer treatment, Amgen said in a statement mid-April.Such tests give the doctor information about a patient’s cancer through an analysis of genes, proteins and other substances, or biomarkers. It’s a way to test if breakthrough therapies, such as Amgen’s KRAS inhibitor, would be a good choice for someone with a specific type of cancer.The program is made up of two components: a financial assistance aspect to help patients with out-of-pocket costs associated with the expensive tests, and a monitoring of the KRAS gene mutation in program participants.Dr. Jennifer King, chief scientific officer of GO2 Foundation for Lung Cancer, said programs like Biomarker Assist make personalized medicine more accessible.“Over the last decade, the cancer community has learned a great deal about precision medicine, particularly for non-small cell lung cancer, but if patients aren’t getting comprehensive biomarker testing, then they are less likely to benefit from all of the therapeutic advancements,” King said in a statement. “We welcome programs like Amgen’s Biomarker Assist because we need support from all stakeholders, including industry, so that comprehensive biomarker testing becomes universal for everyone who is diagnosed with lung cancer.”
Breakthrough Drug, Cancer Program at Amgen
