The U.S. Food and Drug Administration (FDA) has granted fast track status to PC14586, PMV Pharmaceuticals’ lead therapeutic candidate for the treatment of patients with locally advanced or metastatic solid tumors, including breast cancer, who have a specific mutation in the gene that encodes the tumor suppressor protein p53. A fast track designation facilitates the…
The cast of the hit sitcom “Everybody Loves Raymond” reunited online to honor former co-star Peter Boyle for the International Myeloma Foundation’s (IMF) 14th Annual Comedy Celebration. The fundraiser benefits the Peter Boyle Research Fund and supports the IMF’s signature Black Swan Research Initiative. This year’s two-hour free event was chaired by Boyle’s wife, Loraine…
Adding Opdivo (nivolumab) to standard first-line chemotherapy significantly extends overall survival and delays disease progression or death in adults with inoperable advanced HER2-negative stomach cancer, esophageal adenocarcinoma, or gastroesophageal junction (GEJ) cancer, compared with chemotherapy alone, according to interim data from the CheckMate-649 Phase 3 trial. Notably, survival benefits were seen across several patient groups, regardless of…
A trial opened to investigate CFI-400945, by Treadwell Therapeutics, as a potential oral therapy for people with metastatic castration-resistant prostate cancer (mCRPC), the company announced in a press release. It is one of several sub-studies within a larger Phase 2 clinical trial (NCT03385655) that is evaluating various treatment candidates, including targeted therapies, immunotherapies, and chemotherapies, as possible precision…
Under its Pilot Study Awards program, the Rivkin Center is funding innovative research projects that seek to expand current knowledge about ovarian cancer, the non-profit has announced. Awarded grants will provide up to $75,000 over two years for studies involving newer ideas that are not yet widely accepted, and for those whose results are expected…
Adding Ibrance (palbociclib) to standard endocrine therapy failed to prolong the time women with early hormone receptor (HR)-positive, human epidermal growth factor (HER2)-negative breast cancer lived without having their disease return or spread, according to data from a Phase 3 trial. The study, called PENELOPE-B (NCT01864746), was designed to assess if the addition of Ibrance…
First-line maintenance therapy with Darzalex (daratumumab) significantly delays disease progression or death in adults with multiple myeloma who responded to autologous stem cell transplant (ASCT), according to data from the CASSIOPEIA trial’s second part. These findings, from a pre-planned interim analysis conducted by an independent data monitoring committee, indicate that the Phase 3 trial met the main goals of both its…
The U.S. Food and Drug Administration (FDA) has agreed to review applications requesting the approval of Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) for people with advanced renal cell cancer, the most common type of kidney cancer in adults. The applications — requests to extend the indications for Opdivo by Bristol Myers Squibb and Cabometyx by Exelixi — were given priority…
Oncopeptides soon will seek conditional approval of melflufen (melphalan flufenamide) in the EU for the treatment of relapsed or refractory multiple myeloma. The pharmaceutical company now is planning to submit its application — some two years earlier than expected — to the European Medicines Agency (EMA) to request melflufen’s conditional approval. The request was originally intended to…
Adding UV1, Ultimovacs’ experimental cancer vaccine, to Keytruda (pembrolizumab) is safe and shows initial signs of effectiveness in adults with previously untreated metastatic melanoma, according to top-line data from a Phase 1 clinical trial. “The safety profile observed to date in this first cohort [group of patients] of the [UV1-Keytruda] combination study is consistent with the promising…
