Novartis gears up for key expansions of 3 cancer drugs
Novartis said Thursday in a brief, five-sentence press release that it plans to file for an expanded label for its prostate cancer treatment Pluvicto in the second half of this year. The expanded label could potentially make the radiopharmaceutical available to two to three times the number of patients for whom it’s currently approved.
Novartis` largest Pluvicto plant approved by FDA
Novartis has finally become the “pure-play” business that execs have been working toward for the past few years, upping the stakes on its R&D pipeline after what CEO Vas Narasimhan called a “significant pruning of the portfolio.”
EAST HANOVER, N.J., Oct. 23, 2023 /PRNewswire/ -- Novartis today presents data from the Phase III PSMAfore trial at the 2023 European Society for Medical Oncology (ESMO) Congress. Data presented at the Presidential Symposium showed that Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) met its primary endpoint with a clinically meaningful and statistically significant benefit in radiographic progression-free survival (rPFS) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) after treatment with androgen receptor pathway inhibitor (ARPI) therapy, compared to a change in ARPI1.
Novartis` Pluvicto (lutetium (177Lu) vipivotide tetraxetan) Receives Approval in Europe
Enforcement Report - Week of August 23, 2023
Enhanced antitumor activity was shown with the addition of the PARP inhibitor olaparib (Lynparza) to the radioligand lutetium Lu 177 vipivotide tetraxetan (Pluvicto; formerly 177Lu-PSMA-617) in patients with metastatic castration-resistant prostate cancer (mCRPC), according to early findings from the phase 1 LuPARP study (NCT03874884).1
After a shortage prevented prostate cancer patients from getting Novartis’ Pluvicto, the FDA has quickly approved a radiotherapy manufacturing facility to help the company ramp up commercial supply.
For patients with metastatic castration-resistant prostate cancer (mCRPC) who have failed on prior treatments, Novartis’ radiotherapy Pluvicto offers a novel option. But the drug can be hard to come by these days, with supply constraints dogging existing patients and also delaying treatment for potential new takers.