As expected, Novartis’ radioligand therapy Pluvicto crossed the blockbuster sales threshold with one quarter still left of 2024. But some may not be satisfied with the prostate cancer med’s current growth rate.
Thanks to $386 million in third-quarter sales, Pluvicto’s total sales in the first nine months of the year reached $1.04 billion, which marked 47% growth year over year.
The $386 million haul was 2% ahead of analysts’ expectations, according to ODDO BHF. But the number benefited from a $36 million one-time price adjustment in Europe, and with that extra gain removed, the remaining $350 million wasn’t too different from the drug’s $345 million revenue in the second quarter.
For the fourth quarter, Novartis expects Pluvicto performance to be “broadly in line” with Q3, excluding that one-time boost, CEO Vas Narasimhan said during an investor call Tuesday. That’s despite Novartis’ increasing its U.S. sales force in August, launching a direct-to-consumer campaign in September and adding new treatment sites in the U.S.
“Our focus right now is really laying the foundation for the PSMAfore launch in 2025, which would triple the number of patients eligible for Pluvicto,” Narasimhan said.
The chief executive was referring to the key application for Pluvicto in pre-taxane metastatic castration-resistant prostate cancer (mCRPC). After much delay, thanks to the need to follow the phase 3 PSMAfore trial for longer, Novartis has finally filed Pluvicto in that indication with the FDA, which has accepted the application, the company disclosed Tuesday.
Unlike its recent important expansion for Kisqali in early-stage breast cancer, this time around, Novartis didn’t use a priority review voucher for the PSMAfore application to accelerate the FDA’s evaluation, Narasimhan said during a separate press call Tuesday. The company now expects a decision in the first half of 2025.
Novartis chose not to expedite the review upon consultation with the FDA, Narasimhan explained during the investor call. The FDA “wanted flexibility for the timing” in anticipation of potential final overall survival analysis from PSMAfore during the review period, he said.
Novartis had previously pushed back its filing for Pluvicto in earlier treatment of mCRPC because of a preliminary patient survival trend against the radioligand therapy. The company only moved to apply for the expansion after the survival trend turned in favor of Pluvicto during another interim analysis. Apparently, the FDA wants further assurance but doesn’t mind waiting for it in parallel with a positive dataset.
As for the lack of further growth at the moment, Narasimhan noted that the U.S. market is already annualizing in the $1.2 billion-to-$1.4 billion range of peak sales Novartis is expecting for Pluvicto in the post-taxane indication. Plus, the upcoming holiday season is typically a low time for Pluvicto initiation, Narasimhan explained. Per current treatment guidance, patients have to keep their distance from other people post-Pluvicto dosing to reduce radiation exposure to others.
In Europe, where Novartis is still having ongoing pricing negotiations, the company doesn’t see immediate revenue increases.
Altogether, Novartis has put Pluvicto’s peak sales potential in its currently approved post-taxane setting at about $2 billion.
“We expect, as we bring China, Japan and other markets on board, we can reach that $2 billion over time,” Narasimhan said.
Overall, Novartis enjoyed a strong quarter, with $12.8 billion sales beating analysts’ consensus estimates by 2%.
Kisqali continued its momentum, delivering $787 million—40% above its level at the same time last year. Entresto and Cosentyx also contributed to the growth with $1.9 billion and $1.7 billion sales, respectively. And Leqvio is still making progress with $198 million sales compared with $182 million during the second quarter.