J&J gets quick approval for new next-gen prostate cancer drug

The FDA has approved Johnson & Johnson’s next generation prostate cancer drug, apalutamide in an early but tough to treat form of prostate cancer that has not spread.

Approval of the drug, which J&J will market under the brand name Erleada, comes ahead of schedule and at a time when the company’s established prostate cancer blockbuster Zytiga is facing generic competition.

Zytiga is J&J’s biggest selling cancer drug and drew in sales of $755 million in the first quarter alone, up 45% on the previous Q4.

But last month the US Patent & Trademark Office overthrew a key patent that was protecting Zytiga from generic competition until 2027.

Although J&J has appealed, it looks like Zytiga’s period of exclusivity is coming to an end, with generics firms led by Argentum ready to flood the market with cheap copies later this year.

Zytiga also faces competition in metastatic disease from Pfizer/Medivation’s rival Xtandi (enzalutamide) – although J&J has an edge over its rival, which is only approved for use after chemotherapy.

Erleada’s approval comes just at the right time for J&J, as analysts have already said that it could achieve sales north of a billion dollars in a slightly different indication from Zytiga.

The FDA has approved Erleada for patients with non-metastatic castration-resistant prostate cancer and is the first drug to reach market for these patients, who have no treatment options until their cancer spreads.

Approval follows a priority review, where the FDA agrees to review a drug within a six-month timeframe as opposed to the standard 10-month period if it thinks a drug is badly needed.

The FDA was clearly impressed with the results of the SPARTAN trial, which formed the basis of the filing in October as it has approved Erleada well ahead of its target decision date in April.

The phase 3 study involved 1,207 patients and showed Erleada, a next generation androgen receptor inhibitor, reduced risk of distant metastatasis or death by 72%, and increased media metastasis free survival by more than two years compared with the placebo.

Pfizer is also developing Xtandi for nonmetastatic prostate cancer, with some impressive results revealed at the beginning of this month.

But for now J&J and its Janssen unit have the advantage after getting the drug to market first in the US and under review in Europe just last week.

Mathai Mammen

Mathai Mammen,  global head, Janssen Research & Development, said: “The need to delay metastasis is critical to the treatment of prostate cancer. Nearly 90% of patients with castration-resistant prostate cancer will eventually develop bone metastases, at which point the prognosis sharply worsens."