Novartis delays FDA filing for in-demand radiopharma drug

Dive Brief:

  • Novartis is delaying a regulatory submission for its radiopharmaceutical drug Pluvicto in early prostate cancer following mixed results from a late-stage trial, the company said Tuesday as it reported its third quarter earnings. The Swiss drugmaker now plans in 2024 to ask for Food and Drug Administration approval, rather than by the end of this year.
  • Data released Monday at a medical meeting suggested trial enrollees who were assigned to take Pluvicto at the beginning of the trial might not be living longer than those who received hormone therapy. But the results were affected by patients in the hormone therapy arm who “crossed over” to receive treatment with Pluvicto when their disease progressed.
  • Novartis recorded $256 million in Pluvicto sales in the third quarter and $707 million for the first nine months of the year, making it the company’s fastest-growing drug. That growth has been aided by “unconstrained” supply after the FDA’s clearance of manufacturing at a factory in Milburn, New Jersey, which could soon be joined by an Indianapolis site now under FDA review.

Dive Insight:

In its trial, dubbed PSMAfore, Novartis enrolled people whose prostate cancer had worsened after treatment with a hormone therapy like Pfizer and Astellas’ Xtandi. To be included, their disease must also have spread and become resistant to testosterone-suppressing treatments.

The study population represents a much larger indication than currently granted to Pluvicto, which is currently used when patients get sicker after hormone therapy and taxane-based chemotherapy. Novartis expects broader use of its drug to eventually push annual sales above $2 billion.

Late last year, Novartis revealed Pluvicto had met PSMAfore’s primary goal, delaying disease progression. The data presentation at the European Society of Medical Oncology this week showed it reduced the relative risk of progression by 59% over hormone therapies, with patients on Pluvicto living a median of 12 months before progression or death compared with less than six months for those who received hormone therapies.

The overall survival data, which came after an interim analysis, was less conclusive. Because 84% of the study participants given hormone therapy arm “crossed over” to treatment with Pluvicto once their disease worsened, there was no statistical difference in how long patients in either group lived on an unadjusted basis. On an adjusted basis, Pluvicto-treated patients were 20% less likely to have died, Novartis said.

That interim overall survival analysis occurred after 45% of the trial enrollees died. As a result, Novartis will wait until next year to ask the FDA for approval, at which point it could have data from another interim checkpoint.

Pluvicto pairs a radioisotope with a molecule that selectively binds to proteins on tumor cells to provide a targeted radioactive therapy. Novartis’ success with Pluvicto, which it acquired from Endocyte for $2.1 billion, has spurred substantial investment and research into the field, with cancer-drug rivals Roche and Eli Lilly forging deals to get into the field.