FDA approves Pluvicto for PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC), advancing potential new standard of care across metastatic disease

Novartis India terminated its Feb 11, 2022 Distribution and Promotion Agreement with Dr. Reddy’s Laboratories on Aug 7, 2026, effective Sep 30, 2026, ending DRL’s exclusivity and giving Novartis India direct promotion and distribution rights. Separately, Novartis AG’s Pluvicto gained FDA approval for mHSPC; Q2 Pluvicto revenue rose 43% to $651 million.

Biotech roundup reports multiple FDA and EU approvals: Replimune’s TUDRIQEV with Bristol Myers Squibb’s nivolumab for advanced melanoma, Takeda’s ORZEYFUL for narcolepsy type 1, Moderna’s mFLUSIVA flu vaccine for adults 50+, Sanofi’s MenQuadfi expanded EU use, and Novartis’ Pluvicto combo for PSMA+ mHSPC. It also covers Lisata layoffs, Emergent restructuring and Q2 results, and deals including Tarsus-Alkeus and Evotec-Odyssey.

Arkansas Board of Pharmacy voted to suspend enforcement of Act 630, a 2025 law restricting manufacturers’ limited drug distribution networks to favor in-state pharmacies. A federal court preliminarily enjoined enforcement against Novartis, citing likely unconstitutional discrimination under the Dormant Commerce Clause. After Bristol Myers Squibb sued and the AG said the act is likely unconstitutional, the Board authorized settlement and non-enforcement.

The FDA approved Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan) plus an ARPI for adults with PSMA-positive metastatic mAPMN/S prostate cancer. In the phase 3 PSMAddition trial (N=1144), Pluvicto+ARPI cut risk of radiographic progression or death by 28% vs ARPI alone (HR 0.72, P=.002). Updated analysis showed 33% risk reduction (HR 0.67).

The FDA approved Novartis AG’s Pluvicto radioligand therapy for use with an androgen receptor pathway inhibitor in metastatic hormone-sensitive prostate cancer, expanding eligibility nearly twofold versus prior metastatic castration-resistant use. The decision followed Phase 3 PSMAddition results showing 28% and 33% risk reductions. Pluvicto Q2 revenue rose 43% to $651 million.

The FDA approved Novartis’ Pluvicto (lutetium Lu-177 vipivotide tetraxetan) for PSMA-positive metastatic hormone-sensitive prostate cancer, to be used with an androgen receptor pathway inhibitor and androgen deprivation therapy. Based on the PSMAddition phase 3 trial, radiographic PFS improved (HR 0.72). OS data are immature, and grade 3+ adverse events were higher (50.7% vs 43%).