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Opdivo-Cabometyx Granted FDA Priority Review for Newly Diagnosed Advanced Kidney Cancer

Opdivo-Cabometyx Granted FDA Priority Review for Newly Diagnosed Advanced Kidney Cancer

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…

Darzalex Delays Disease Progression After ASCT, Phase 3 Trial Reports

Darzalex Delays Disease Progression After ASCT, Phase 3 Trial Reports

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…

Pilot Study Grants Available for Ovarian Cancer Research

Pilot Study Grants Available for Ovarian Cancer Research

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…

New Targeted Therapy Trial Opens, Part of PC-BETS Metastatic CRPC Study

New Targeted Therapy Trial Opens, Part of PC-BETS Metastatic CRPC Study

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…

Opdivo Combo Found to Extend Survival in Advanced Stomach, Esophageal Cancers

Opdivo Combo Found to Extend Survival in Advanced Stomach, Esophageal Cancers

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…

‘Everybody Loves Raymond’ Cast Reunites for Virtual Fundraiser

‘Everybody Loves Raymond’ Cast Reunites for Virtual Fundraiser

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…

First Patient Dosed in Biomarker Study of Oral Alzheimer’s Therapy, ALZ-801

First Patient Dosed in Biomarker Study of Oral Alzheimer’s Therapy, ALZ-801

A first patient has been dosed in a Phase 2 trial evaluating the effects of ALZ-801 on disease-related biomarkers in people with early Alzheimer’s disease, who have a specific genetic variant associated with an increased risk of disease progression. “This biomarker study is a key element of our overall Alzheimer’s clinical development program for ALZ‑801,”…

FDA Grants Fast Track to PC14586, Potential Therapy for Specific p53 Mutation

FDA Grants Fast Track to PC14586, Potential Therapy for Specific p53 Mutation

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…

3 Companies Join Forces to Test Personalized ‘Teaching’ Vaccine for Ovarian Cancer

3 Companies Join Forces to Test Personalized ‘Teaching’ Vaccine for Ovarian Cancer

TransGene, NEC, and BostonGene have entered a strategic collaboration to test TG4050, an investigational personalized vaccine that aims to treat ovarian and head and neck cancers, according to a press release. TG4050 is an individualized therapy that stimulates a patient’s immune system into attacking cancer cells by “teaching” it which cells are malignant — based on the…

FDA Clears Ezra Prostate AI, a First for Cancer Imaging

FDA Clears Ezra Prostate AI, a First for Cancer Imaging

The U.S. Food and Drug Administration (FDA) has cleared Ezra Prostate AI, an artificial intelligence (AI) program designed to increase the efficiency with which radiologists analyze images of the prostate in order to diagnose prostate cancer. The program, which is expected to decrease the cost of prostate MRIs, is the first-ever prostate segmentation AI to…