AstraZeneca and Daiichi Sankyo’s drug Enhertu is on fire, winning FDA approval for lung cancer, marking its second positive regulatory decision in a week.
This FDA approval announced Friday Covers the treatment of adults with advanced non-small cell lung cancer (NSCLC) expressing the oncoprotein HER2. These cancers must have received at least one prior systemic therapy. According to the FDA, Enhertu is now the first drug approved to treat NSCLC characterized by HER2 mutations.Along with the new approval for Enhertu, the agency also approved a Thermo Fisher Scientific companion diagnostics This mutation was detected.
Enhertu is an antibody drug conjugate, a therapy consisting of a targeted antibody linked to a toxic drug payload. Enhertu’s antibody component is designed to target HER2, a protein expressed on the surface of certain cancer cells. The drug was first approved by the FDA in 2019 to treat HER2-positive breast cancer that has spread. August 6, FDA expands drug approval to include treatment of breast cancer characterized by HER2 levels previously thought too low for targeted therapy. The decision defines a new class of breast cancer patients, bringing them the first targeted therapy.
The latest approval of Enhertu means the drug is now available to treat the most common type of lung cancer. Non-small cell lung cancer accounts for about 80 percent of lung cancer cases, according to the American Lung Association. The approval is based on an interim analysis of Phase 2 data that enrolled 152 participants with HER2-positive NSCLC. The primary study objective was to measure the objective response rate to the drug, defined as the proportion of patients who exhibited a complete or partial response to infusion therapy. The objective response rate was 58%, and the median duration of response was 8.7 months. Response rates were consistent for both doses tested. Higher rates of pulmonary complications were observed at higher doses; approval covers lower doses.AstraZeneca Say Results of the NSCLC clinical trial will be presented at a future medical meeting.
The most common adverse reactions reported in clinical trials included nausea, low white blood cell counts, anemia and low levels of immune cells called neutrophils — all of which were consistent with previous tests of the drug. The most serious complication observed in the study was interstitial lung disease, which is characterized by scarring and inflammation. The drug’s label includes a boxed warning about this side effect.
Dave Fredrickson, executive vice president of AstraZeneca’s oncology business unit, said in a prepared statement. “Today’s news provides the opportunity for these patients to benefit from targeted therapy and underscores the importance of detecting predictive markers, including HER2 in lung cancer, at diagnosis to ensure patients receive the most appropriate therapy for their specific disease. Treatment.”
The regulatory decision for Enhertu in NSCLC was accelerated approval based on less evidence than is required for standard approval. AstraZeneca and Daiichi Sankyo need to conduct additional clinical trials to confirm the drug’s benefit for patients. The drug’s first approval in HER2-positive breast cancer was an accelerated approval. That status shifted to full approval in May when the drug moved up the cancer treatment options list and the FDA approved the drug as a second-line treatment. Enhertu is also approved for the treatment of advanced HER2-positive gastric cancer.
Here’s a recap of some additional regulatory news from the past week:
–Tabrecta, a Novartis drug, Accelerated approval in 2020 FDA-approved for advanced non-small cell lung cancer. Targeted therapy is a small molecule designed to target a specific genetic signature called mesenchymal-epithelial transition (MET) exon 14 skipping. Convert drug status to fully approved is based on additional clinical testing showing response rates consistent with earlier data.
— The European Medicines Agency told ProQR Therapeutics that the company needed another clinical trial of its RNA therapy to treat a rare eye disease. therapy Failed a key study earlier This year, but ProQR had hoped that additional analysis of clinical data would be enough to support regulatory submissions. Instead of doing another study, Netherlands-based biotech says it will seek to partner with all of its ophthalmic assets It will focus on developing drugs for liver and central nervous system diseases based on its RNA platform technology.
— The FDA rejected Acadia Therapeutics’ application to expand approval of its antipsychotic drug Nuplazid to include Alzheimer’s disease. According to Acadia, the FDA stated that the data submitted were not from adequate and well-controlled studies, and The company must conduct another clinical trial. The drug was first approved in 2016 to treat hallucinations and delusions in people with Parkinson’s disease.
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