- The Food and Drug Administration has approved Erleada to treat a second type of prostate cancer, giving the relatively new Johnson & Johnson drug a potential advantage over a rival therapy from Astellas and Pfizer.
- Erleada is now cleared to treat patients whose cancer spread beyond the prostate but could still be responsive to hormone therapy. That type of disease is called metastatic castration-sensitive prostate cancer, or mCSPC, and is diagnosed in approximately 40,000 U.S. patients each year according to J&J.
- The approval may help strengthen J&J's shakier position in the prostate cancer drug market. While a long-time leader, the company began facing generic competition to its flagship product Zytiga late last year. Zytiga also competes with Astellas and Pfizer's Xtandi — which, while not approved for mCSPC, has U.S. patent protection until 2027.
Generic competition is eating away at J&J's prostate cancer empire.
Sales of Zytiga (abiraterone acetate) totaled $698 million in the second quarter, reflecting a 23% decline year over year. According to Iqvia data cited by SVB Leerink, J&J held 56% of the abiraterone acetate market for the week ending Sept. 6, a slip from the 63% it held a week prior. Apotex and Mylan, which each launched a generic form of Zytiga over the last year, had market shares of 26% and 16%, respectively.
While Erleada (apalutamide) isn't big enough to warrant a line item in J&J's financial reports, its early growth is helping offset the Zytiga troubles. Chris DelOrefice, vice president of investor relations, said on the company's second quarter earnings call that the drug had gained four points of market share in the U.S. for its initial indication: non-metastatic castration-resistant prostate cancer.
Xtandi (enzalutamide) presents a barrier to growth, however. Pfizer has touted how Xtandi outpaced Erleada early on in the non-metastatic, castration-resistant setting — and how, more recently, it overtook Zytiga to become the leading branded agent for metastatic castration-resistant prostate cancer monotherapy.
The new approval puts Erleada on more even ground with Zytiga, which regulators have already OK'd to treat mCSPC, and differentiates it from Xtandi, which has yet to secure such an approval.
Yet Erleada may not hold that advantage for long. In August, the FDA accepted and granted priority review to a supplemental New Drug Application for Xtandi in the mCSPC setting. An approval decision is expected sometime in the fourth quarter.