Breakthroughs dominate oncology meet in Chicago; FDA announces Project Facilitate

By PharmaCompass

2019-06-06

Impressions: 147 Article

During the recently held conference organized by the American Society of Clinical Oncology in Chicago, doctors reported that newer drugs are substantially improving the chances of survival for some people with hard-to-treat forms of lung, breast and prostate cancer.

The big news from the meet pertained to Amgen’s promising lung cancer drug — AMG510. This experimental Amgen drug targets a specific genetic mutation, and it significantly reduced tumor size in half of the evaluated patients with advanced lung cancer in a small, early-stage trial.

Out of 10 heavily pre-treated lung cancer patients who were given the oral drug AMG510 daily, five had tumors shrink in size by at least 50 percent, including one with no evidence of malignancy.

The disease was stabilized in four other patients, while the cancer progressed in one. In this dose-ranging study, half of the evaluated patients were given the highest dose (960-milligram) of AMG510. No serious side effects were reported, as per the data presented at the meet.

The Amgen drug targets a mutated form of a gene known as KRAS — one of the most common mutations found in non-small cell lung cancer (NSCLC), which accounts for up to 85 percent of lung cancers. If approved, AMG510 could become the first drug to target KRAS.

Among studies on newer oncology drugs, a study said immunotherapy drugs such as Keytruda have transformed the treatment of many types of cancer, but they’re still fairly new and don’t help most patients.

The cost of these drugs is a huge drawback — many cost US$ 100,000 or more a year. What patients pay out of pocket depends on their insurance cover, income and other criteria.

The studies, which were published by the New England Journal of Medicine, had been sponsored by drug companies.

The longest study yet of Keytruda in patients with advanced lung cancer revealed that 23 per of those who were given the drug as part of their initial therapy survived at least five years. In comparison, 16 percent of those who tried other treatments first survived at least five years.

There were similar studies on patients with breast cancer. They showed how adding Novartis drug Kisqali to the usual hormone therapy increased survival rate of patients. There was also a study on Pfizer’s Xtandi for men with prostate cancer.

News from the oncology meet at Chicago had a bearing on Wall Street. Amgen, for instance, saw its stock jump 4 percent after news on AMG 510.

FDA’s Project Facilitate: This week, the US Food and Drug Administration (FDA) launched a new pilot program — Project Facilitate — aimed at helping physicians complete expanded access requests for cancer patients.

Under Project Facilitate, FDA has set up a call center to serve as a single point of contact for oncologists to reach out to for assistance with completing and submitting expanded access requests for single patient investigational new drug (IND) applications.

“Through this pilot program, experienced FDA oncology staff will be available to support physicians and other healthcare professionals with their questions, assist in filling out the appropriate paperwork and acting as a facilitator for the process,” said Richard Pazdur, director of FDA’s Oncology Center of Excellence.

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“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

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