Most Popular News Stories on OBR Daily
(Stanford Medicine) July 31, 2019 - A combination of two drugs keeps patients with chronic lymphocytic leukemia disease-free and alive longer than the current standard of care, according to a phase-3 clinical trial of more than 500 participants conducted at the Stanford University School of Medicine and multiple other institutions. The results of the trial are likely to change how most people with the common blood cancer are treated in the future, the researchers believe.
(Roll Call) Aug 5, 2019 - Provision could force drugmakers to cut patient assistance for chemotherapy drugs. A little-noticed provision of the Senate Finance Committee drug price bill is alarming some doctors, with at least one group warning it could harm patients with fragile medical conditions.
(Xconomy New York) July 29, 2019 - Merck this morning announced that a combination of its drug pembrolizumab (Keytruda) and chemotherapy succeeded in a Phase 3 study in breast cancer, a potentially notable advance for immunotherapy in treating the disease. Merck said that Keytruda and chemotherapy beat chemo alone when given to patients with triple-negative breast cancer in a study called Keynote-522. The regimen was administered during what’s known as the neoadjuvant setting, before patients have surgery to remove a tumor.
(Merck) July 23, 2019 - Merck, known as MSD outside the United States and Canada, and Eisai today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with LENVIMA, the orally available kinase inhibitor discovered by Eisai, for the potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma (HCC) not amenable to locoregional treatment. This is the third Breakthrough Therapy designation for the KEYTRUDA plus LENVIMA combination and is based on updated interim results from the Phase 1b trial KEYNOTE-524/Study 116. An earlier interim analysis was presented at the American Association for Cancer Research (AACR) Annual Meeting 2019.
(Reuters) July 30, 2019 - Unusually high numbers of U.S. lymphoma patients are choosing experimental treatments over expensive cell therapies sold by Gilead Sciences Inc and Novartis AG, new data shows, helping explain why sales of the two products have not met rosy expectations. Both Gilead’s Yescarta and Novartis’s Kymriah - which are part of a class of therapies known in the medical field as “CAR-T” - were approved in 2017. But government and private health plans have balked at their high price of at least $373,000 for a one-time treatment before hospital costs, which can bring the bill for a single patient to over a million dollars.
(BioPharma Dive) July 25, 2019 - Bristol-Myers Squibb's chances of challenging Merck & Co. in the market for lung cancer drugs shrank on Wednesday, when the pharma announced mixed clinical results from a sprawling study of its immunotherapy drugs Opdivo and Yervoy. While combining the two drugs together helped previously untreated lung cancer patients live longer than those given just chemotherapy, pairing Opdivo with chemo didn't show a clear statistical benefit over chemo alone, according to high-level data from a study known as CheckMate-227.
(The Telegraph [UK]) Aug 12, 2019 - Bladder cancer survival rates have fallen due to a world-wide shortage of a crucial drug, figures suggest. New Office for National Statistics data shows the chances of living five years beyond diagnosis dropped 2.5 per cent between 2016 and 2017 to 52.6 per cent.
(AHA) Aug 5, 2019 - Many men with prostate cancer rely on common testosterone-blocking drugs as a part of their treatment. But those so-called antiandrogens also might put them at risk for a deadly heart condition, according to new research. In a study published Monday in the American Heart Association journal Circulation, researchers looked at how several testosterone-blocking drugs affect the heart's QT interval – the time it takes the heart cells to recharge in between beats.
(Lilly) July 30, 2019 - Eli Lilly and Company today announced that Verzenio (abemaciclib) demonstrated a statistically significant improvement in overall survival in the Phase 3 MONARCH 2 clinical trial. These results were from a pre-planned interim analysis and are definitive. MONARCH 2 evaluated Verzenio in combination with fulvestrant for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with endocrine therapy. The study included both pre/peri- and postmenopausal women.
(Nektar) Aug 1, 2019 - Nektar Therapeutics and Bristol-Myers Squibb today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb's Opdivo® (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma. The Breakthrough Therapy Designation is based on clinical data which were recently reported at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting from the cohort of patients with metastatic melanoma that were treated with the doublet therapy in the ongoing PIVOT-02 Phase 1/2 clinical study.