Opdivo's survival benefit inspired FDA to act fast on NSCLC approval: Pazdur

Dr. Richard Pazdur

When Opdivo showed it could prolong the lives of lung cancer patients, Bristol-Myers Squibb ($BMY) quickly broadcast the data. And the pharma world was sufficiently impressed. But the FDA was so impressed with the survival data on the new immunotherapy, it was already working on a new approval for the drug.

That's the news from Dr. Richard Pazdur, who heads up the agency's Office of Hematology and Oncology products. In an interview with The Cancer Letter, Pazdur said Opdivo's survival data came into the FDA Dec. 19, before the results were unblinded for Bristol-Myers. And the "magnitude of the survival effect" triggered quick action from the get-go, he said.

"With regard to the impetus for this rapid action, we began working immediately on this review and submission strategy after being informed of the survival results. This was prior to BMS having been informed of the results since they were still blinded," Pazdur said to The Cancer Letter.

The agency wanted to quickly get those findings into Opdivo's product label and open up approvals for second-line and third-line treatment of squamous non-small cell lung cancer. And it did--Bristol-Myers had only just announced that the agency accepted its app for expanded approval when the FDA turned around and announced the new indications.

The Checkmate-017 trial was the first to show a cancer immunotherapy beat another oncology drug--in this case docetaxel--on overall survival stats. And as Pazdur points out, that particular trial focused on patients with refractory squamous NSCLC, a group of patients with few treatment options.

Pazdur's comments suggest that strong data from other Opdivo studies--Checkmate-057, in nonsquamous NSCLC and Checkmate-025 in kidney cancer--could inspire quick FDA action, too, Leerink analyst Seamus Fernandez said in an investor note. "[W]e believe both trials could not only end early, but also benefit from rapid inclusion into Opdivo's label," Fernandez wrote.

The FDA official also suggested that the bar for future approvals in squamous disease could be higher. Now that Opdivo has so decisively trounced the chemo med, docetaxel shouldn't be used as a comparator in future studies in squamous NSCLC, Pazdur suggests (as cited by Fernandez in his note).

Meanwhile, the speedy Opdivo approval in lung cancer not only gives BMS more time to get the jump on competitors such as Merck & Co. ($MRK) and Roche ($RHHBY) but also offers a boost for the Opdivo marketing folks, Fernandez figures. "[T]he mandate the FDA felt to inform patients and physicians through product labeling ought to translate into continued publicity and rapid uptake of Opdivo in squamous disease," the analyst said. And with that, Opdivo might just beat Leerink's current 2015 sales estimate of $600 million, he said.

- see the Cancer Letter interview

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