While investment has slowed in radiopharmaceuticals, analysts predict increased interest to come as Novartis shows just how successful radiopharmaceuticals can be.
Sales of Novartis’ radioligand Pluvicto are climbing higher as the Swiss pharma eyes the first line setting—a result that is buoying others in the space, too.
Novartis reported $564 million in sales of Pluvicto for the third quarter, growth of 45% over the same period last year, according to the pharma’s latest earnings report. The results were bolstered by the FDA’s March approval for the drug’s use in pre-chemotherapy metastatic castration-resistant prostate cancer (mCRPC).
This new indication accounted for 60% of new patient starts, Novartis CEO Vas Narasimhan said during a third-quarter earnings call on Oct. 28. Pluvicto is now surpassing chemotherapy in terms of market share for first line therapy.
Previously, the therapy was indicated for use after chemo. Meanwhile, Novartis has been working to expand the radioligand around the globe, with 25 countries now offering it and the company rolling out a pre-filled syringe to ease the treatment logistics.
Narasimhan said that all systems are go for Pluvicto to reach its peak sales potential, which should be around $5 billion. The pre-chemotherapy indication will likely drive the drug to the $3 billion-plus range, according to the CEO..
Meanwhile, Novartis still wants to add to Pluvicto’s label, with a submission for metastatic hormone sensitive prostate cancer (mHSPC) already on the FDA’s desk. The company is also working toward oligometastatic prostate cancer for a filing around 2028. The mHSPC label would get the drug into the $5 billion range, Narasimhan said.
The results are great for Novartis, but analysts also say that the company is validating the space for everyone else. Fellow Big Pharmas Eli Lilly, Bristol Myers Squibb, AstraZeneca and Sanofi made big deals in radiopharmaceuticals in the past few years, seeking to enter a market that Novartis commanded with Pluvicto and Lutathera.
Novartis is showing that “radiopharmaceuticals can be commercially scalable and move upstream to [first line] settings,” Jefferies wrote in response to Novartis’ earnings report.
The biotechs coming behind Novartis also know the power of Pluvicto. “We’re very lucky as a medical community to have this first product, for it to have been successful and to really pave the way for the field,” Christian Behrenbruch, CEO of Telix Pharmaceuticals, said at the H.C. Wainwright 27th Annual Global Investment Conference in September.
“Everyone in the nuclear medicine community stands on the sideline and cheers for Novartis,” Behrenbruch continued. “Because it’s a tough sell. Going out and selling radioactive drugs to oncologists is a tough sell.”
Oncologists have traditionally been leery of nuclear medicine, the CEO said, as radiopharmaceuticals have struggled to shake off the stigma of earlier, more damaging radiation therapies. But Novartis helped break down that barrier as the technology improved. Now, a company like Telix can further hone radiopharmaceuticals. The company is doing so with a biologic, which differs from Pluvicto’s small molecule approach. Behrenbruch said this should ease potential adverse events.
A Centerpiece of Cancer Care
Jefferies noted that radiopharma has been quieter on the deal front in recent months. But with Novartis proving the market potential, the firm said that could change. Buyers will be interested in different isotopes and other cancer markets with $1 billion potential, the analysts predicted.
In March, William Blair estimated that radiopharmaceutical biotechs had raised $900 million in the previous nine months, proving that “the field remains hot.” Besides Telix, other biotechs working in the space include Actithera, Abdera Therapeutics and Bicycle Therapeutics.
To change the narrative in cancer care, radiopharmaceutical developers will need to show that their candidates can exceed existing standards of care as investors will closely examine these comparisons, William Blair noted. “It is therefore imperative for the radiopharmaceuticals field to demonstrate differentiation, either through deeper or longer responses or an improved patient selection strategy.” Better patient selection can be done using imaging agents—another key part of the radiopharmaceutical business that has risen along with therapeutics, the firm wrote.
In October, Sanofi and partner OranoMed’s somatostatin receptor–targeted alpha therapy reported a “clinically meaningful” overall response against gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in a Phase II clinical trial.
The therapy would compete with Novartis’ first radiopharma entry, Lutathera, which was first approved in 2018. Compared with Pluvicto, Lutathera achieved a more modest $213 million for 11% growth in the third quarter. Novartis is eyeing a label expansion for the therapy, with a submission in GEP-NETs expected in 2028.
Meanwhile, Narasimhan previewed strong results ahead for the fourth quarter. He did note, however, that radioligands typically have a slowdown around Thanksgiving and Christmas as patients divert treatment to allow for family time.
Looking ahead, Jefferies predicted the therapy will continue growing into 2026—albeit at a slightly slower rate. “Pluvicto’s launch is on the steep part of the S-curve.”
According to Narasimhan, the Pluvicto success also helped build confidence in Novartis’ own radioligand pipeline, which includes assets from the $1 billion acquisition of Mariana Oncology in May 2024.
The company is currently advancing therapies in 10 different indications. These next therapies will benefit from Novartis’ existing infrastructure built out by Pluvicto and Lutathera if they are eventually approved, Narasimhan told investors. “[That] was a very important element for us to strategically solve. And in my view, we have solved the challenge of rolling out radioligand therapy in the United States.”
William Blair was similarly optimistic about the space as a whole, writing in its March report: “We believe that over the next two years, the field will reach an inflection point as the therapeutics class emerges from a niche modality to become one of the centerpieces of the cancer treatment paradigm.”
