The U.S. Food and Drug Administration (FDA) has granted priority review to an application seeking the approval of Libtayo (cemiplimab) as a first-line therapy for advanced non-small cell lung cancer (NSCLC) and high PD-L1 levels, according to a press release. This priority status is expected to shorten Libtayo’s regulatory review to six months from the standard 10 months, and a decision…

The U.S. Food and Drug Administration (FDA) has expanded the approval of Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic test for identifying advanced or metastatic breast cancer patients suitable for treatment with Novartis‘ Piqray (alpelisib). The approval covers men and postmenopausal women who have experienced disease progression during or after endocrine therapy. Additional new indications include those for patients…

CLR 131, Cellectar Biosciences’ lead experimental candidate, resulted in a 40% response rate among people with multiple myeloma who failed to respond to three treatment modalities, according to additional data from the CLOVER-1 clinical trial. These triple-refractory patients, who previously failed to respond to at least one immunomodulatory treatment, one proteasome inhibitor, and one anti-CD38…

Imfinzi (durvalumab) continues to demonstrate a sustained survival benefit in patients with inoperable, locally advanced non-small cell lung cancer (NSCLC) who had not progressed after platinum-based chemotherapy and radiation therapy, a four-year analysis shows. Updated findings from the PACIFIC Phase 3 trial (NCT02125461) demonstrate that, at four years, more participants receiving Imfinzi were alive, compared with…

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…

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…

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…