国际新闻精选周二（2017年3月28日）

FDA approves maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers

The U.S. Food and Drug Administration today approved Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy.【阅读全文】

Six new medicines backed for EU approval

Six new medicines, including three orphan drugs for rare diseases, have been backed for European Union approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Orphan medicine Dinutuximab beta Apeiron (dinutuximab beta) has been put forward for a marketing authorisation under exceptional circumstances for the treatment of high risk forms of neuroblastoma, a rare cancer arising from neural crest cells, which are involved in the foetal development of the nervous system and other tissue.【阅读全文】

Nivolumab, pembrolizumab exhibit different toxicity profiles as melanoma monotherapy

Nivolumab and pembrolizumab exhibited different toxicity profiles and appeared associated with different adverse event frequencies when used as monotherapy for melanoma, according to study results presented at HemOnc Today Melanoma and Cutaneous Malignancies.

An analysis of FDA–approved dosing revealed higher rates of diarrhea, nausea and vomiting among nivolumab-treated patients, and higher rates of myalgia and cough in pembrolizumab-treated patients.【阅读全文】

Chinese drug approval boosts AstraZeneca's lung cancer hopes

AstraZeneca has won approval for its lung cancer pill Tagrisso in China, a key market for the potential blockbuster medicine. Tagrisso is designed to help cancer patients with certain genetic mutations that are very common in China and the regulatory green light boosts the British drugmaker's prospects in a key therapy area.【阅读全文】

Pumped by an early glimpse of efficacy, Newron charts a pivotal course for schizophrenia drug

Just a few days after Newron finally landed an FDA approval for Parkinson’s add-on therapy Xadago after a 4-year regulatory odyssey, the biotech is back with a snapshot of early data on a new treatment for schizophrenia. And while they were able to pull out positive data from the Phase IIa study of evenamide, investigators plan to make some significant changes to the next study that could provide more plainly promising pivotal results.【阅读全文】

ArQule Announces Top-Line Results of Phase 3 Clinical Study of Tivantinib in Hepatocellular Carcinoma in Japan

rQule, Inc. (Nasdaq: ARQL) today reported that its partner, Kyowa Hakko Kirin, announced top-line results of the JET-HCC Phase 3 trial of tivantinib in Japan, and that the trial did not meet its primary endpoint of progression free survival (PFS).

JET-HCC is a randomized, double-blind placebo-controlled study that enrolled approximately 190 Japanese patients with c-Met diagnostic-high inoperable hepatocellular carcinoma (HCC) with a history of prior sorafenib therapy, to evaluate the efficacy and safety of tivantinib.【阅读全文】

ERYTECH Reports Positive Phase 2b Data for eryaspase for the Treatment of Metastatic Pancreatic Cancer

ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris - ERYP), a French clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced positive topline results from its Phase 2b clinical study evaluating its product candidate, eryaspase (GRASPA®), in combination with chemotherapy for the treatment of second-line metastatic pancreatic cancer. The multicenter, randomized Phase 2b study met its prespecified co-primary endpoints, and showed significant improvement in both progression-free survival (PFS) and overall survival (OS) in patients treated with eryaspase combined with chemotherapy compared to chemotherapy alone.【阅读全文】

MSD’s Keytruda closer to classical Hodgkin Lymphoma nod

MSD’s anti-PD-1 therapy Keytruda has taken a giant leap towards being approved in Europe for the treatment of classical Hodgkin Lymphoma (cHL).

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has backed expanding the list of approved uses for the drug to include relapsed or refractory cHL in adults who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.【阅读全文】

Allergan, Paratek hit late-stage acne goals, prep for sarecycline NDA

Allergan and partner Paratek Pharmaceuticals have hit their primary endpoints in two key phase 3 acne trials for their investigational med sarecycline.

The pair will now seek an FDA NDA in the second half of the year after the two “replicative” late-stage tests that saw the med outdo placebo in treating inflammatory acne lesions in subjects with moderate to severe acne.

Neither company went into exact details on the figures, but said in a statement that sarecycline “was statistically significantly (p<0.004) superior to placebo with respect to primary efficacy endpoints.”【阅读全文】

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