Novartis CEO Basu Narasimhan is doubling down on Pluvicto’s $5 billion peak sales forecast, even though the company has given up on expanding the label in Europe.
Novartis has withdrawn its application to the European Medicines Agency for Purvict as a pre-chemotherapy treatment for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), the companies announced on Friday.
Narasimhan told reporters on a conference call Tuesday that the withdrawal “reflects a different perspective on what is an appropriate comparison in a pre-taxane situation.” Although the PSMAfore trial tested Pluvicto against a modified androgen receptor pathway inhibitor, some doctors argue that chemotherapy should be the standard of care for this patient population.
European authorities have requested a new trial, but Novartis doesn’t think it’s worth it, Narasimhan said.
Despite the regulatory setback, Mr. Narasimhan dismissed the impact of the withdrawal, noting that the company had not factored the European findings into its estimate of Purvikt’s $5 billion in peak sales because it expected a backlash from regulators.
Meanwhile, PSMA-driven radioligand therapy (RLT) has gained popularity since the FDA’s approval of pretaxane about a year ago. According to ODDO BHF, Pluvicto’s first quarter sales were $642 million, up 70% year over year on a constant currency basis and 3% above analyst consensus.
Particularly in the U.S., Pluvicto’s sales increased 76%, with more than 70% of its business coming from the use of pretaxane, Narasimhan said on a separate conference call with investors on Tuesday.
“I think it all gives us confidence that we were able to create an RLT standard that is widely available in the communities we serve, and also prepares us well for our future radioligand therapy portfolio in the coming years,” said Narsinghan.
The company expects the next inflection point for the drug to come from potential FDA approval for metastatic hormone-sensitive prostate cancer later this year, which would increase the number of patients eligible for Pluvicto by 75%.
Pluvicto may not remain unbeatable in the PSMA space for long. Astellas Pharma has entered into an agreement to accelerate the development of Vir Biotechnology’s PSMAxCD3 masked T cell engager candidate VIR-5500, with a Phase 3 mCRPC trial scheduled for 2027.
Additionally, outside of PSMA, there is an influx of new candidates into the broader prostate cancer field, including antibody-drug conjugates that are already in Phase 3.
However, Novartis remains committed to Pluvicto and its radioligand approach.
“Patients are increasingly demanding a very convincing profile of their quality of life, and that’s what Pluvicto provides,” Narasimhan said on a media call. “So far, the side effect profile of the T-cell engagers we have investigated continues to result in a high rate of severe or strong reactions, and we should be cautious about jumping into the field.”
The Novartis CEO added: “We will continue to evaluate the situation.” “Right now, we think Pluvcito has a very attractive profile and should hopefully be able to reach well over $5 billion in sales.”
Pluvicto is one of the key growth drivers for Novartis as it climbs over Entresto’s huge patent cliff. The drug was the company’s biggest seller until it lost U.S. exclusivity for the heart failure drug last summer.
As expected, Entrest’s sales fell sharply in the first quarter, falling 46% to $1.3 billion in constant currencies, 7% below analysts’ expectations, according to ODDO.
Entresto’s free fall resulted in Novartis’ overall first-quarter sales of $13.1 billion, a 5% decline. Core operating profit plunged 14% due to lower sales and increased investment in research and development.
