6 days ago
FDA OKs First-of-Its-Kind Lung Cancer Pill
approval to a first-of-its-kind pill for a type of lung cancer known as non-small-cell lung cancer (NSCLC).
The drug, called sunvozertinib and sold as Zegfrovy, is for adults with advanced non-small-cell lung cancer (NSCLC). It works for people whose cancer has a certain genetic change, called an EGFR exon 20 insertion mutation. This drug is used when the cancer has gotten worse during or after chemotherapy. It is taken by mouth once a day, making it easier for patients to stick to their treatment, which can go on for a long time.
The FDA also approved a test called the Oncomine Dx Express Test. This test helps find the EGFR exon 20 insertion mutation in people with NSCLC who might get Zegfrovy. The test gives results in just 24 hours, so doctors can find the mutation fast and start treatment sooner.
NSCLC is the most common type of lung cancer, accounting for about 80% to 85% of all cases. Among these, EGFR exon 20 insertions are the third most common type of EGFR mutation and play a key role in helping cancer cells grow and spread. These cancers are often hard to treat because the mutations can vary from person to person, making it difficult to find effective treatment options.
The FDA's approval was based on a clinical trial involving 85 people with advanced NSCLC and EGFR exon 20 insertion mutations whose cancer had worsened despite chemotherapy. They received oral Zegfrovy once daily until their cancer got worse or side effects became too severe. Results showed about 46% of them responded to the treatment, with benefits lasting for more than 11 months.
Zegfrovy works by blocking bad EGFR proteins that help cancer cells grow. It is made to target many kinds of EGFR changes, including exon 20 insertion mutations, but it mostly leaves healthy cells alone. It may also help treat other rare EGFR changes and HER2 exon 20 insertion mutations.
Ongoing approval may depend on confirming how well the drug works in further studies, according to a news release from Dizal, the drug's maker.
In a statement, Pasi A. Jänne, MD, PhD, of the Dana-Farber Cancer Institute of Harvard Medical School and lead principal investigator of the clinical trial, said results from the study show that Zegfrovy works well for patients of different backgrounds. He noted that it's easy to take because it's just one pill a day, which helps people stick to their treatment – something that's really important as lung cancer care becomes more like managing a long-term illness.
People taking Zegfrovy should know that the drug may cause serious side effects, including lung inflammation, stomach and skin problems, eye issues, and harm to an unborn baby.
