Chasing $3B sales mark, AZ’s Tagrisso picks up full FDA approval

Tagrisso
AstraZeneca's Tagrisso won a full FDA approval on Friday after the agency weighed phase 3 data.

With a full FDA approval granted Friday, AstraZeneca’s lung cancer med Tagrisso is in position to become the standard of care for certain patients with the deadly disease, a company exec predicts, and help it achieve the full sales potential that the U.K. drugmaker foresees.

On the strength of new phase 3 data, AstraZeneca’s lung cancer med Tagrisso notched its approval to treat patients with EGFR T790M mutation-positive non-small cell lung cancer who have already received treatment with a tyrosine kinase inhibitor. It’s the first drug approved in that indication, according to the company’s release.

Pitted against chemotherapy in a phase 3 trial, Tagrisso improved progression-free survival by 10.1 months, compared to 4.4 months from chemo.

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Those results were strong enough to win the favor of the FDA, and AstraZeneca’s chief medical officer Sean Bohen said in a statement the regulatory blessing “reinforces the potential of Tagrisso to become the standard of care” for the patient population.

Tagrisso previously won accelerated FDA approval back in November 2015 after the agency weighed data from two earlier studies showing 57% of patients in one study and 61% of patients in the other experienced a complete or partial reduction in tumor size. Following that approval, AZ placed a $12,750-per-month sticker on the med in the U.S.

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Anticipated by company execs to hit $3 billion in sales, Tagrisso is now licensed in more than 45 countries. After an access delay last year in AZ’s home country, U.K. authorities in October placed the med on the revamped Cancer Drugs Fund, making the med available to about 300 patients in England and Wales. Tagrisso was the first med to be placed on the new program.

AZ is also testing its therapy in previously untreated patients, an indication with a larger population that would give Tagrisso a boost toward its growth ambitions. Bernstein analysts recently predicted the drug will hit $2.76 in sales by 2025.

Friday’s approval came just days after authorities in China signed off on the drug. According to AZ, lung cancer is the most common cancer in the country and the top cancer-related killer there. Tagrisso was AZ’s first drug approved under China’s priority review pathway.

RELATED: China proposes new FDA rules to speed up foreign drug approvals

Earlier this month, regulators in China published a slate of suggestions to speed up foreign drug approvals.