A newly-approved drug for breast cancer patients may prove a lifeline for patients whose tumors have defied traditional treatment. The FDA has approved the drug Etcamah, which works against resistant tumors, and which saw patients in clinical trials go a median of 16 months before the cancer worsened. This was in comparison to those who stayed on their original hormone therapy, who went 9.2 months.
Now, the FDA has granted accelerated approval—a faster path for drugs that treat serious illnesses—thanks to the early signs of benefit for patients. When contacted for comment, the FDA directed Newsweek to a press release confirming it had expanded treatment options for adult patients with advanced breast cancer, including accelerated approval to Etcamah. Etcamah is taken alongside existing cancer medicines known as CDK4/6 inhibitors, which target specific enzymes in cancer cells.
It will be used for adult breast cancer patients with HR positive, HER2 negative breast cancer which has spread beyond the breast or into nearby tissue. These cancers are usually treated with drugs to cut off the tumor's estrogen supply, but the tumors can change a gene called ESR1 to allow the cells to keep growing. However, the FDA has also authorized a blood test—Guardant360 CDx—which finds the ESR1 change, flagging a resistance earlier than a scan would, and allowing patients to switch to Etcamah earlier.
Donna McNamara, breast medical oncologist, John Theurer Cancer Center at Hackensack University Medical Center, told Newsweek the FDA's approval of Etcamah is a "transformative shift" for patients as it introduces a "proactive, rather than reactive, treatment model." "For the first time, doctors can use a specialized companion blood test to detect an ESR1 mutation—an early indicator that the cancer is developing resistance to standard hormone therapy—before any tumor growth actually appears on an imaging scan," she said. She called it a "massively positive leap forward for precision oncology" as it validated the use of blood tests to "outsmart breast cancer before it causes further physical harm." McNamara pointed out, however, that due to the accelerated approval, there are "important caveats." "Regulators are still waiting on mature data to determine if this early-switch strategy actually helps patients live longer overall (overall survival), rather than simply delaying immediate progression," she said. There are also potential serious side effects for the use of the drug, including heart arrhythmia, so both doctors and patients will need to "carefully monitor and weigh these risks against the groundbreaking benefits of this proactive new approach." More studies are required to confirm just how much the newly-approved drug helps.
Dave Fredrickson, of drug makers AstraZeneca, said in a statement that the Etcamah combination is a "new approach using circulating tumor DNA and is the first and only medicine of its type in the 1st-line setting." Contact Newsweek editors on this story: Kara Dolman and Emma Lee-Sang
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