In a new health technology assessment, the U.K. National Institute for Health and Care Excellence (NICE) has voiced misgivings about the evidence behind the use of MRI/ultrasound fusion systems to perform needle biopsy for suspected prostate cancer. NICE said the evidence for these systems could be bolstered by additional research comparing fusion biopsy to cognitive fusion-directed biopsy, suggesting that companies working in this space have a significant evidentiary lift in front of them.
Researchers from Sun Yat-Sen Memorial Hospital and affiliated organizations published data from a study that aimed to explore the mechanism of prostate cancer (PCa) metastasis to discover an intrinsic biomarker for metastatic PCa (mPCa).
The U.S. FDA’s Oncologic Drugs Advisory Committee has recommended by a wide majority that the PARP inhibitor Lynparza (olaparib) in a combination therapy for treating prostate cancer should be restricted to only patients whose tumors have a BRCA mutation.
The U.S. FDA’s Oncologic Drugs Advisory Committee meets April 28 to discuss the future of Astrazeneca plc and Merck & Co. Inc.’s supplemental NDA for Lynparza (olaparib) for an expanded label to treat prostate cancer. It has a few bones to pick. The FDA said it is concerned that the efficacy and safety have not been demonstrated outside of the small population of patients with tumor BRCA mutations and that the addition of olaparib to abiraterone may cause harm in patients who are definitively negative for tumor BRCA mutations.
Researchers from Arvinas Inc. and affiliated organizations presented the discovery and preclinical evaluation of ARV-766, a novel androgen receptor (AR) degrading proteolysis targeting chimera (PROTAC), being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
As prostate cancer progresses, tumors lose the androgen receptor (AR) on which initial treatment is based. Oftentimes, such patients also lose expression prostate-specific membrane antigen (PSMA), which is the target of approved agent Pluvicto (lutetium (177Lu) vipivotide tetraxetan; Novartis AG) as well as a number of experimental drugs. Such patients can no longer benefit from either androgen- or PSMA-directed therapy.
Montelino Therapeutics LLC has described proteolysis targeting chimera (PROTAC) compounds comprising an E3 ubiquitin ligase binding moiety coupled to an androgen receptor variant 7 (AR-v7)-targeting moiety through a linker. They are reported to be useful for the treatment of cancer.
Global interest in radiopharmaceuticals is growing, and some big deals in the space have sparked interest in the last few years. Novartis AG has spent about $6 billion in acquisitions and is seen as the global leader.
After spending decades developing targeted chemotherapy and bringing a dozen or so compounds into the clinic, Fusion Pharmaceuticals Inc. Chief Scientific Officer Christopher Leamon switched careers to focus on radio-oncology because he saw the need for “a really strong bomb to target cancer to get it to respond.” That was radiotherapy, said Leamon, who was one of the scientific founders of Endocyte Inc., which Novartis AG acquired.
