An FDA panel's provisory vote of confidence for a drug from Sprout Pharmaceuticals Inc. that could become the first ever therapy for hypoactive sexual desire disorder (HSDD) in premenopausal women lifted shares of a would-competitor: Palatin Technologies Inc., which is advancing its candidate through phase III trials.
Complete with an assay that helps select eligible patients, the approved prostate-cancer (PC) drug Xtandi (enzalutamide) from Medivation Inc. and partner Astellas Pharma Inc. turned up hopeful phase II results in androgen-receptor (AR)-positive triple-negative breast cancer (TNBC), detailed at the recently concluded meeting of the American Society of Clinical Oncology in Chicago.
CHICAGO – No one was surprised to see immune-based therapies taking much of the air time at this year's American Society of Clinical Oncology (ASCO) meeting, since they've dominated the key scientific powwow in cancer for several years, and a fountain of outcomes showed that targeted drugs, in combination regimens as well as single agents, still have plenty going for them.
CHICAGO – Following up last March's investor-pleasing top-line phase III data from PERSIST-1, which tested the next-generation JAK2/FLT3 multikinase inhibitor pacritinib in myelofibrosis (MF), CTI Biopharma Corp. and partner Baxter International Inc. offered more results that better characterize the drug's position with regard to the marketed JAK2 inhibitor Jakafi (ruxolitinib), developed by Incyte Corp. and partner Novartis AG.
CHICAGO – Bristol-Myers Squibb Co.'s programmed cell death-1 inhibitor Opdivo (nivolumab), cleared by the FDA late last year for melanoma and in March for squamous non-small-cell lung cancer (NSCLC), worked better than the firm's other approved melanoma drug Yervoy (ipilimumab) in patients with previously untreated cases of the deadly skin cancer not only when the two drugs were given together but also when Opdivo was administered by itself.
CHICAGO – Brain cancer got plenty of buzz at the ASCO annual meeting, with a plenary talk about the risk/benefit tradeoff in whole-brain radiation therapy (WBRT) and the unveiling of detailed positive results from a 73-patient phase II trial by Celldex Therapeutics Inc. with Rintega (rindopepimut), an immunotherapy vaccine targeting epidermal growth factor variant III (EGFRvIII) in recurrent glioblastoma multiforme (GBM).
CHICAGO – Vowing to make precision medicine more than a hackneyed phrase, researchers at the ASCO annual meeting disclosed the launch of three separate but complementary efforts in what amounts to the "expansion of an ongoing dream," said past ASCO president Clifford Hudis.
CHICAGO – Genomics may matter more than histology in predicting the response rate of patients treated with the programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab, Merck & Co. Inc.), as a phase II study has turned up the first genomic marker – mismatch repair (MMR) deficiency – that foretells success, results showed at the American Society of Clinical Oncology (ASCO) annual meeting.
Bolstering its capacity in chimeric antigen receptor T (CAR-T) cell therapies as well as the high-affinity T-cell receptor (TCR) approach, Juno Therapeutics Inc. expects that its already flexible strategy next will be able "not only to insert a gene but also change or modify genes already present inside the cell," chief financial officer (CFO) Steve Harr told BioWorld Today, thanks to a pact signed with Editas Medicine Inc.