Bayer's Nubeqa one step closer to blockbuster status thanks to FDA priority review in potential new use

Aiming to make noise in oncology, Bayer is counting on prostate cancer drug Nubeqa as a potential blockbuster.

On Tuesday, the company took a step toward that goal, earning priority review status for the med in an indication that would broaden Nubeqa’s reach. Already approved for early-stage disease, Bayer’s label expansion bid centers on Nubeqa’s use against metastatic hormone-sensitive prostate cancer (mHSPC).

Nubeqa, an oral androgen receptor inhibitor co-developed by Orion, is used in combination with chemotherapy docetaxel and androgen deprivation therapy (ADT).

The FDA is reviewing the application under the Project Orbis initiative, which allows multiple countries to concurrently review submissions. Applications for widening the use of Nubeqa have also been submitted to regulators in Europe, China and Japan.

Backing the application are results from the phase 3 Arasens trial which showed that Nubeqa added to the standard of care (chemo + ADT) reduced the risk of death by 32.5% without producing additional side effects.

The data prompted Bayer to increase its Nubeqa peak sales estimate from 1 billion euros ($1.1 billion) to 3 billion euros ($3.4 billion).

Nubeqa won approval for men with non-metastatic castration-resistant prostate cancer (nmCRPC) in July 2019. The company has yet to report sales of the drug but said it expected Nubeqa to garner between $200 and $250 million last year.

The label expansion would allow Bayer to compete with Pfizer and Astellas’ Xtandi, which was originally approved for nmCRPC in 2012 and generated sales of $4.2 billion last year, and Johnson & Johnson’s Erleada, which was approved in 2018 and registered $1.3 billion in sales last year.

Earlier this year, Bayer demonstrated its increased focus on developing cancer treatments by luring Christine Roth from GlaxoSnithKline to become its new oncology chief.