An independent data monitoring committee (DMC) has deemed it unlikely that a combination of endocrine therapy and Pfizer’s Ibrance (palbociclib) will show benefits over standard therapy at delaying or preventing cancer spread in patients with early breast cancer. The ongoing Phase 3 PALLAS trial had been testing the efficacy of adding Ibrance to conventional endocrine…

Karyopharm Therapeutics is asking that Xpovio (selinexor) be approved with Velcade (bortezomib) and low-dose dexamethasone to treat people with multiple myeloma after at least one line of therapy. The request was submitted to the U.S. Food and Drug Administration (FDA) in the form of a supplemental new drug application (sNDA). It is based on new data…

The U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) for the treatment of people with advanced, inoperable, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) previously treated with fluoropyrimidine– and platinum-based chemotherapy. The approval came after the regulatory agency granted priority review to the application. It was based on data from the ATTRACTION-3 Phase…

Adding Xtandi (enzalutamide) to standard androgen deprivation therapy (ADT) significantly prolonged life by nearly a year for men with high-risk, non-metastatic castration-resistant prostate cancer (CRPC), final data from a Phase 3 clinical trial show. The results, “Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer,” were published in the New England Journal of Medicine and presented…

A combination of bevacizumab and Zejula (niraparib) is significantly better than Zejula alone at extending the time without disease progression in people with platinum-sensitive relapsed ovarian cancer, findings from a clinical trial show. The combination also delayed the need for subsequent treatment by prolonging time without disease worsening, and showed a trend toward better survival rates,…

Genetic screenings of the general population for prostate cancer are feasible, safe, and may be effective at identifying the disease in apparently healthy men who might otherwise remain undiagnosed, according to data from a pilot study in the United Kingdom. Study findings were presented in the oral presentation, “BARCODE 1: A pilot study investigating the…

VBL Therapeutic’s investigational therapy VB-111 (ofranergene obadenovec) continues to show promising response rates in women with platinum-resistant ovarian cancer, with more than half of patients enrolled in a Phase 3 trial responding to a combination treatment. Since the OVAL trial (NCT03398655) has met pre-specified criteria, as an interim analysis found, an independent data safety monitoring…

Ontruzant (trastuzumab-dttb), a biosimilar to Genentech‘s Herceptin (trastuzumab), will now be made available in the U.S. as a treatment for HER2-overexpressing breast cancers as well as for stomach cancers, according to a press release from Merck. Merck will be launching the antibody treatment in the U.S., as part of an agreement with Samsung Bioepis, Ontruzant’s developers. It…

The European Commission (EC) has approved a new under-the-skin (subcutaneous), fixed-dose formulation of Janssen’s Darzalex (daratumumab) for the treatment of adults with multiple myeloma. The approval of the new type of delivery applies to all indications for which the therapy’s original intravenous (into-the-vein) formulation is currently approved. That includes its use with newly diagnosed patients…

Adding Beigene‘s experimental therapy tislelizumab to standard first-line chemotherapy significantly delays disease progression or death in patients with advanced squamous non-small cell lung cancer (NSCLC), data from a Phase 3 clinical trial shows. The combination also increased the proportion of patients responding to treatment and the duration of such responses, compared to chemotherapy only. The…

Urged by Prostate Cancer UK, NHS England is making Xtandi (enzalutamide) and Zytiga (abiraterone acetate) available during the COVID-19 pandemic for men with newly diagnosed advanced prostate cancer. Access to chemotherapy for these new patients has been stopped in the U.K. due to the nationwide lockdown. “We are delighted that NHS England have taken the…

Genetic tests to assess the risk of breast and ovarian cancer can be performed remotely in the safety of the patients’ homes, according to data from an early Phase 1 trial. The trial findings also showed that genetic counseling sessions performed before and after testing can be skipped entirely without causing additional distress to patients.…