AstraZeneca's blockbuster Tagrisso gets major boost with FDA OK for early lung cancer use

AstraZeneca’s Tagrisso is already swimming in billions in annual sales after setting a new standard for treating metastatic EGFR-mutant non-small cell lung cancer. And now, with an FDA go-ahead in early use, the drug is up for a major expansion, with, as one analyst put it, “logarithmic demand.”

The FDA has approved Tagrisso for postsurgery use among patients with early-stage EGFR-mutated NSCLC to prevent cancer from returning after complete tumor removal, the agency said Friday.

The green light makes Tagrisso the first drug allowed in the so-called adjuvant setting for EGFR-positive NSCLC, the FDA noted. “With this approval, patients may be treated with this targeted therapy in an earlier and potentially more curative stage of non-small cell lung cancer,” Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence, said in a statement.

Tagrisso proved its worth in early-stage NSCLC in the phase 3 Adaura trial, which was stopped two years early on overwhelming efficacy.

When used as an adjuvant treatment after surgery, Tagrisso cut the risk of disease recurrence or death by a whopping 83% compared with placebo in patients with stage II and IIIA disease, according to data featured at this year’s American Society of Clinical Oncology (ASCO) virtual annual meeting. 

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But they weren’t the only ones who benefited. Researchers noted clinically meaningful improvements across patients with different stages of the disease, spanning from stage IB to stage IIIA. The new early-stage approval could add about 60,000 patients across the U.S., Europe, Japan and China, which is about a quarter of the size of Tagrisso’s current metastatic patient pool, Dave Fredrickson, head of AZ’s oncology business unit, said during an interview at ASCO.

The other good news for AZ? Early-stage patients have less aggressive disease and can stay on adjuvant treatment for long periods of time—potentially more than three years in the setting, where it could soon become the standard of care, SVB Leerink analyst Andrew Berens wrote in a Friday note to clients.

Berens labeled the adjuvant nod as an “inflection point in revenue growth as the trajectory steepens from an expected logarithmic demand.” Previously, based on the ASCO readout, he forecast an additional $5.6 billion in peak worldwide sales for Tagrisso, bringing the drug’s total to an impressive $16 billion. In the first nine months of 2020, the drug hauled in $3.17 billion after 38% year-over-year growth.

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Berens pointed to Tagrisso’s efficacy in patients whose disease has spread to the brain as a “key commercial driver.” In the Adaura study, Tagrisso slashed the risk of central nervous system recurrence or death by 82% versus placebo, according to data presented at this year’s European Society of Medical Oncology (ESMO) virtual congress. 

Meanwhile, data showing whether Tagrisso could lengthen lives weren't mature by ASCO, but they favored Tagrisso at the time. Previously, in the Ctong1104 study, AZ’s first-generation EGFR inhibitor Iressa showed a significant 44% reduction in disease recurrence over chemotherapy, although the benefit didn’t translate into an extension of life.

The FDA doled out the adjuvant nod under Project Orbis, collaborating with drug regulators from other countries—Canada, Australia, Brazil, Switzerland and Singapore, in this case—to facilitate concurrent submission and review of the drug. Applications for this indication are also under review in China and the EU.