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Regulators in Europe have given the green light to Pierre Fabre’s Hemangiol for the treatment of proliferating infantile haemangioma.
The European Commission has granted the French company authorisation to market Hemangiol, an oral solution of the beta-blocker propranolol specially developed for paediatric use. The thumbs-up follows an approval in the USA in March; it will be launched across the Atlantic as Hemangeol next month.
Kevin Grogan is the World News Online Editor for PharmaTimes and has been writing about the industry since 1997, having previously worked as a journalist on rock/pop music publications, while contributing articles to the likes of The Independent and the Manchester Evening News on football. He specialises in the business developments of the pharmaceutical industry – financial results, mergers and acquisitions, alliances, legal tussles – and has a particular interest in emerging markets and the prospects for biotech.
Gilead Sciences’ closely-watched hepatitis C drug Sovaldi has been given the green light in Europe.
The European Commission has granted marketing authorisation for Sovaldi (sofosbuvir) 400mg tablets
which, as part of HCV combination therapy with peg-interferon and ribavirin, offers cure rates of around 90% in previously-untreated adults. However, most significant is that the once-daily nucleotide analogue polymerase inhibitor is the first all-oral treatment option for up to 24 weeks for patients unsuitable for interferon.
WHIPPANY, N.J. and SOUTH SAN FRANCISCO, Calif., Aug. 30, 2013 /PRNewswire/ — Bayer HealthCare and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced today that the European Commission has approved Stivarga® (regorafenib) tablets for the treatment of adult patients with metastatic colorectal cancer (mCRC).
In September 2012, Stivarga was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.
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February 25, 2013 — The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease.
GIST is a tumor in which cancerous cells form in the tissues of the gastrointestinal tract, part of the body’s digestive system. According to the National Cancer Institute, an estimated 3,300 to 6,000 new cases of GIST occur yearly in the United States, most often in older adults.
Stivarga, a multi-kinase inhibitor, blocks several enzymes that promote cancer growth. With this new approval, Stivarga is intended to be used in patients whose GIST cancer cannot be removed by surgery or has spread to other parts of the body (metastatic) and is no longer responding to Gleevec (imatinib) and Sutent (sunitinib), two other FDA-approved drugs to treat GIST.
“Stivarga is the third drug approved by the FDA to treat gastrointestinal stromal tumors,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It provides an important new treatment option for patients with GIST in which other approved drugs are no longer effective.”
Stivarga was approved in September 2012 to treat colorectal cancer. It is marketed by Bayer HealthCare Pharmaceuticals, based in Wayne, N.J. Gleevec is marketed by East Hanover, N.J.-based Novartis, and Sutent is marketed by New York City-based Pfizer.
Regorafenib (BAY 73-4506, commercial name Stivarga) is an oral multi-kinase inhibitor developed by Bayer which targets angiogenic, stromal and oncogenic receptor tyrosine kinase (RTK). Regorafenib shows anti-angiogenic activity due to its dual targetedVEGFR2-TIE2 tyrosine kinase inhibition. It is currently being studied as a potential treatment option in multiple tumor types.
Metastatic colorectal cancer
Regorafenib demonstrated to increase the overall survival of patients with metastaticcolorectal cancer and has been approved by the US FDA on September 27, 2012.Stivarga is being approved with a Boxed Warning alerting patients and health care professionals that severe and fatal liver toxicity occurred in patients treated with Stivarga during clinical studies. The most common side effects reported in patients treated with Stivarga include weakness or fatigue, loss of appetite, hand-foot syndrome (also called palmar-plantar erythrodysesthesia), diarrhea, mouth sores (mucositis), weight loss, infection, high blood pressure, and changes in voice volume or quality (dysphonia).
- “Bayer Announces New Data on Oncology Portfolio To Be Presented at the ECCO-ESMO Congress 2009″. Retrieved 2009-09-19.
- “Phase III Trial of Regorafenib in Metastatic Colorectal Cancer Meets Primary Endpoint of Improving Overall Survival”. Retrieved 2011-10-26.
- “FDA approves new treatment for advanced colorectal cancer”. 27 Sep 2012.
- “FDA Prescribing Information”. 27 Sept 2012.
Regorafenib from the structure consists of three simple aromatic ring structure, which fragments can be connected from urea by the corresponding two aniline with phosgene or triphosgene prepared by oxygen fragments can be connected SNAr from the corresponding phenol by reaction of. Carboxylic acid 1 by esterification of Thionyl Chloride 2 , methyl amine solution to 2 the ester group is converted to an amide to obtain 3 , 3 , and 4 in alkaline conditions by SNAr reaction of 5 , 5 , and then the isocyanate 6 ( from the corresponding aniline with phosgene or triphosgene was obtained) to obtain the Regorafenib.
Oncopeptides AB, a company working to enhance oncology therapies, announced that the first patient has been dosed as part of a phase 2 study in multiple myeloma patients with its drug candidate melflufen (previously called J1). The trial is an open-label phase 2 study, designed to determine the level of efficacy of melflufen in combination with dexamethasone, for late stage, relapsing or relapsing/refractory patients
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