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Bayer bags FDA nod for early prostate cancer drug darolutamide

new competition in the market


Bayer and Orion have US approval for their castration-resistant prostate cancer (CRPC) therapy darolutamide, setting up a market clash with Pfizer/Astellas and Johnson & Johnson.

The FDA approved darolutamide under the Nubeqa brand name for men with non-metastatic CRPC, which is shaping up to be a hotly-contested category in prostate cancer.

The US go-ahead comes three months ahead of the FDA’s deadline and is based on the phase 3 ARAMIS trial, which compared darolutamide to placebo when given as an add-on to androgen deprivation therapy (ADT).

The results – published in the New England Journal of Medicine in March – showed that metastasis-free survival was significantly longer with Bayer and Orion’s drug, at 40 months versus 18 months for placebo.

Now its approved, Nubeqa will go head-to-head in the non-metastatic CRPC market with J&J’s Erleada (apalutamide) – a follow-up to its Zytiga (abiraterone) brand which is now subject to generic competition – as well as Pfizer/Astellas’ Xtandi (enzalutamide).

Zytiga is only approved for metastatic CRPC and, as Xtandi and Erleada were only approved for non-metastatic CRPC in the last few months, Nubeqa has an opportunity to gain ground quickly in this patient setting.

Bayer and Orion think that will happen as they believe Nubeqa offers a safety advantage compared to its rivals that prompted the FDA to give its marketing application a priority review, with fatigue as the most common side effect reported in ARAMIS.

The aim of treatment at this point is to delay the spread of the disease and limit side effects of therapy, given patients generally feel healthy and may be taking the drug for three or four years.

Bayer and Orion predict Nubeqa will grow quickly into a €1bn-plus product, although some analysts have suggested that may be a tough proposition given that its efficacy is comparable to Erleada and Xtandi, and physicians have more experience with the rival drugs.

For patients and prescribers, it means an additional drug choice for a critical stage of prostate cancer that currently has few treatment options.

It is estimated that around 73,000 men in the US will be diagnosed with non-metastatic CRPC this year, around 40% of all prostate cancer cases. Around a third of them will go on to develop a metastasis within two years.

Meanwhile, another phase 3 clinical trial called ARASENS is ongoing and is testing darolutamide in metastatic hormone-sensitive prostate cancer (HSPC) with results due in 2022.

Bayer says it has also submitted darolutamide in the EU, Japan, and additional countries around the world. The German company licensed rights to darolutamide from Orion in 2014 .

Article by
Phil Taylor

31st July 2019

From: Regulatory



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