Novartis' radiotherapy Pluvicto nabs FDA approval for prostate cancer, with $2B-plus peak sales expectations

Novartis has pushed its second radioligand therapy over the FDA finish line, and the Swiss pharma has more than $2 billion in peak sales expectation linked to the new launch.

Wednesday, the FDA approved Novartis’ Pluvicto, previously known as 177Lu-PSMA-617, for patients with metastatic castration-resistant prostate cancer (mCRPC) who test positive for the prostate-specific membrane antigen (PSMA) with an FDA-approved imaging diagnostic agent. Eligible patients must also have already tried an androgen receptor inhibitor and taxane-based chemotherapy.

Novartis has predicted Pluvicto could reach over $2 billion in peak sales as it angles for other prostate cancer areas. Evaluate Vantage recently assigned $851 million to the drug’s estimated 2026 sales.

The drug sits among 20 potential billion-dollar launches Novartis has planned by 2026 to drive midterm growth as it hopes to surmount $9 billion worth of patent cliffs in the coming years, including megablockbuster heart drug Entresto.

Pluvicto marks the second radiopharmaceutical treatment coming out of Novartis. The drug was the centerpiece of the company’s $2.1 billion acquisition of Endocyte in 2018, which was made to complement the $3.9 billion Advanced Accelerator Applications buy earlier.

For Pluvicto’s launch, Novartis is relying on the lessons from Lutathera, its first radioligand therapy, which is indicated for neuroendocrine tumors, Susanne Schaffert, Ph.D., president of Novartis Oncology, said in an interview with Fierce Pharma during this year’s J.P. Morgan Healthcare Conference.

“What we focus on is really the collaboration with the oncologist and a radio oncologist or a nuclear medicine physician, that is very critical,” Schaffert said.

Radioligand therapies like Pluvicto combine a tumor-targeting compound with a therapeutic radioactive particle. Once inside the blood system, Pluvicto binds to prostate cancer cells that express PSMA, and energy emissions from the radioactive agent kill off the target cells and nearby cells. PSMA is highly expressed in more than 80% of prostate cancer patients, according to Novartis.

With Lutathera, Novartis already has several hundred certified centers to give radioligand therapies, Schaffert said, and the company is looking to further expand that network and raise awareness among patients to offer them more options.

Novartis has a dedicated field sales force for prostate cancer and a commercial team focused on nuclear medicine centers to handle logistics and supplies. “That’s what we learned [from Lutathera], you need probably both capabilities to drive an efficient launch,” Schaffert said.

Pluvicto’s efficacy profile is well-received among physicians, Schaffert noted. In the phase 3 Vision trial, Pluvicto, used alongside standard of care, pared down the risk of death by 38% over standard treatment alone in previously treated, PSMA-positive mCRPC patients. Patients who took the radiotherapy lived median 15.3 months, versus 11.3 months for the control group.

Novartis is also evaluating Pluvicto in other prostate cancer settings. The phase 3 PSMAfore study is pitting the radiotherapy against an androgen receptor inhibitor in chemo-naïve patients with mCRPC who were previously treated with a different androgen-receptor-directed therapy. And the phase 3 PSMAaddition trial is using Pluvicto for metastatic hormone-sensitive prostate cancer.

The FDA has simultaneously cleared Novartis’ Locametz, an imaging agent that can identify PSMA-positive tumors through a PET scan.