AstraZeneca’s breast cancer pill gets approval from the FDA

AstraZeneca Plc’s breast cancer pill was approved by the U.S. Food and Drug Administration, a win for the drugmaker following an earlier vote against the medicine by the agency’s advisory panel.

The drug, camizestrant, was authorized in an accelerated approval process and can be used in combination with other cancer medicines in patients who have a genetically driven form of metastatic breast cancer.

AstraZeneca has said camizestrant, which will go by the brand name Etcamah, has the potential to eventually bring in more than $5 billion in annual sales. Wall Street isn’t so optimistic: Current estimates from analysts surveyed by Bloomberg put sales in 2032 at nearly $2.3 billion.

Earlier this year, the FDA’s Oncology Drugs Advisory Committee voted against the medicine, finding it didn’t have a “meaningful benefit” for patients. In Friday’s approval, however, the agency said the medicine will give women with breast cancer an additional way to treat the disease.

Etcamah works as a hormone therapy by stopping estrogen from stimulating cancer cells, which helps prevent those cells’ growth. The drugmaker has shown the pill can help delay disease progression by more than six months.

The drug’s patients are those with breast cancer who have a specific mutation that can develop during treatment with an endocrine therapy. Patients will need to have an FDA-authorized test showing they have this mutation before receiving Etcamah.

Under Chief Executive Pascal Soriot, AstraZeneca has launched a raft of blockbuster cancer drugs. The company is looking to secure continued growth from its pipeline of oncology drugs while also positioning itself to compete in the red-hot market for weight-loss treatments.

Furlong writes for Bloomberg.