- CEO says competing products cleared `far faster' than expected
- Lung cancer drug to be submitted in first half of next year
AstraZeneca Plc may shelve a plan for seeking accelerated approval of a key experimental cancer drug because Bristol-Myers Squibb Co. and Merck & Co. moved faster to crowd the U.S. market for lung tumors.
The U.K. drugmaker had hoped a mid-stage trial of durvalumab, dubbed Atlantic, for advanced lung cancer would support a filing for the drug as a monotherapy with a form of accelerated regulatory approval. But competing products won clearance “far faster” than expected, Chief Executive Officer Pascal Soriot told reporters on a conference call on Thursday.
“The likelihood that Atlantic as a single-arm study would be able to support registration and approval decreases as a result,” Chief Medical Officer Sean Bohen said on the call.
AstraZeneca will likely submit durvalumab to U.S. regulators in the first half of next year. The pharmaceutical company is trailing three competitors with drugs that target lung cancer by harnessing the body’s own immune system, Goldman Sachs Group Inc. analysts have said.
Bristol-Myers and Merck are eating into AstraZeneca’s turf by seeking permission to sell their respective cancer drugs, Opdivo and Keytruda, to treat deadly lung tumors as well. Opdivo, first approved for patients with advanced melanoma last December, was cleared for lung patients on March 4.
Last month, it also won approval almost three months ahead of schedule from the Food and Drug Administration for a broader population of lung cancer patients. A week prior to that, Keytruda was also cleared to treat some patients with advanced lung cancer.
AstraZeneca’s long-range forecast for reaching $45 billion in sales by 2023 remains even without accelerated approval for durvalumab, since that was considered an upside scenario, Soriot said. It may still be first to market with durvalumab for other types of cancers, and also in combination with other medicines such as tremelimumab, he said.