On March 11, 2014 a periodic safety update was reported to have been added to the EPAR for Yervoy (External Source EMA, Bristol-Myers Squibb, MAR 11, 2014, View Source [SID:1234500262]).
A review of cases of anaphylaxis or cytokine release syndrome events identified a total of 6 cases: two of the 6 cases had limited information for assessment. Nevertheless, there have been cases of anaphylactic reactions, resulting in hospitalization in at least one patient; and for which stopping the medication and supportive care was needed in all reported cases. Due to the characteristics of the cases (rapid time to onset and severity of the events) the PRAC considered that anaphylactic reactions should be included in section 4.8 of the SmPC, with a frequency based on clinical trials, i.e. very rare (<0.01% (1/12881)). The package leaflet is updated accordingly. The CHMP agrees with the scientific conclusions made by the PRAC.
Commission decision was issued on DEC 18, 2013.
Author: [email protected]
Bayer and Onyx Report Phase 3 Study Results of NEXAVAR� (sorafenib) as Adjuvant Treatment for Patients with Liver Cancer Who Have Undergone Surgery or Local Ablation
On March 11, 2014 Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals announced that a Phase 3 trial (NCT00692770) evaluating the investigational use of NEXAVAR (sorafenib) tablets as an adjuvant treatment for patients with hepatocellular carcinoma (HCC), or liver cancer, who had no detectable disease after surgical resection or local ablation, did not meet its primary endpoint of improving recurrence-free survival (Press release Amgen, MAR 11, 2014, View Source;p=RssLanding&cat=news&id=1907747 [SID:1234500257]). The safety findings were consistent with the known profile of sorafenib. Data from this study will be submitted for presentation at an upcoming scientific congress.
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Experimental breast cancer drug to be trialled in lung cancer patients
An experimental drug olaparib, originally designed to treat breast cancer, is now to be tested in patients with advanced lung cancer (Press release Cancer Research UK, MAR 11, 2014, View Source [SID:1234500252]).
Olaparib, a PARP inhibitor, will be given after chemotherapy to patients with non-small cell lung cancer (NSCLC) to see if it delays the growth of their tumor. Around half of NSCLCs have faults in one of the ways they repair DNA damage. Research has shown that adding a PARP inhibitor makes it even harder for the cancer to repair this damage. Olaparib is also being tested in phase III trials for ovarian and stomach cancers.
The phase II trial will recruit over 100 people with advanced non-small cell lung cancer at 25 hospitals around the UK. It is funded by Cancer Research UK and AstraZeneca through a National Cancer Research Network initiative and is being co-ordinated by Cancer Research UK’s Wales Cancer Trials Unit at Cardiff University and Velindre NHS Trust in Cardiff.
(Press release, New Amsterdam Sciences, MAR 10, 2014, View Source!news/nws17/B15A676B-EE12-429B-8F67-3D4B19755DBE/new-amsterdam-sciences-secures-research-and-funding-support-from-the-national-institute-of-health [SID:1234505522])
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(Report, JHL Biotech, MAR 10, 2014, View Source,%20a%20leading%20online%20provider%20of%20biopharmaceutical%20information(1).pdf [SID:1234503386])
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