AZ’s breast cancer treatment gains approval from European Commission

AstraZeneca and MSD‘s Olaparib has been approved by the European Commission for the treatment of germline BRCA-mutated HER2-negative metastatic breast cancer. The approval allows for the first PARP inhibitor approved in Europe for patients with this difficult-to-treat disease, and the third EU approval for Olaparib. The European commission made the approval based on data from

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FDA approves Pfizer’s breast cancer biosimilar

US Patients will now be able to access another biosimilar version of Trastuzumab with the FDA approval of Pfizer’s Trazimera in the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Data supplied with the application supported the similarity of Trazimera to its reference

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Novartis’ Afinitor Approved for Breast Cancer by FDA

Novartis announced on Friday that they have received approval from US regulators for Afinitor as a treatment for advanced breast cancer. The US Food and Drug Administration (FDA) have given the thumbs up to Afinitor (everolimus) for use with Pfizer’s Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.  The

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Eisai’s Halaven Receives Final Draft “No” From NICE

In final draft guidance given yesterday, the National Institute for Health and Clinical Excellence (NICE) announced that they are not recommending Eisai’s Halaven (eribulin) for the treatment of locally-advanced or metastatic breast cancer in people whose disease has progressed after at least two chemotherapeutic regimens for advanced disease. Although the evidence shown to NICE’s independent

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NICE Reject Breast Cancer Drug Faslodex

England and Wales’ cost watchdog, NICE, yesterday reiterated their assessment that AstraZeneca’s breast cancer drug Faslodex does not represent good use of NHS funds and has not been proven to be better than current treatments. The National Institute for Health and Clinical Excellence (NICE) has published their  final appraisal determination, saying that they do not

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