The US regulators have approved a label update to BMS’s Opdivo, waving through a new dosing option for the immunotherapy of every four weeks. The company says the approval will allow physicians to customise patient care with the option of using the new dose of 480mg every four weeks in addition to the previously available
NICE has supported NHS use of Janssen’s Darzalex via the Cancer Drugs Fund (CDF) for some adults with previously treated multiple myeloma. Darzalex is a humanised monoclonal antibody that works by binding to a signalling molecule found on the surface of multiple myeloma cells called CD38, with the aim to trigger the patient’s own immune
Mylan is the first pharma company to gain US approval for a biosimilar of Roche’s lucrative cancer antibody, Herceptin. The biosimilar, Ogivri, developed by Mylan and Biocon, was approved by the FDA for HER2-positive breast or metastatic stomach cancer, the same indications as Herceptin. It brought in almost $7bn in sales last year, with around
BMS’s Opdivo is on track to add resected high-risk advanced melanoma to its current list of indications, after receiving a priority review from the US FDA. The regulatory agency has already granted Opdivo breakthrough therapy designation for this setting, marking its seventh such designation. Murdo Gordon, Chief Commercial Officer at BMS, said: “Priority review of
Patients who have received at least one prior therapy for multiple myeloma in Scotland will soon have access to Amgen’s Kyprolis in combination with dexamethasone through the NHS, following a recommendation by the Scottish Medicines Consortium (SMC). This is a big achievement for the American biopharma, as the drug is the first and only proteasome
NICE are backing controlled use of targeted breast cancer radiotherapy treatment alongside further research. The National Institute for Health and Care Excellence recently published draft guidance recommending the Intrabeam Radiotherapy System (Carl Zeiss UK) as an option for patients with early forms of breast cancer.
The US Food and Drug Administration has approved Roche-group Genentech’s application to market Avastin for patients with a specific type of ovarian cancer. The drug has been cleared for use, either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, to treat patients with platinum-sensitive recurrent
The US FDA has approved Janssen’s Darzalex in combination with other drugs, to be used as second line therapy for patients with bone marrow cancer. The drug was approved in combination with Celgene’s Revlimid and dexamethasone, or Janssen’s Velcade and dexamethasone. The market for multiple myeloma drugs is competitive, as there is a variety of
Novartis has announced that the FDA has granted a breakthrough therapy designation to LEE011 (ribociclib) as first line treatment in HR+/HER2- advanced breast cancer.
Opdivo, Bristol-Myers Squibb’s immunotherapy, can now be used to treat more patients with lung cancer and those with kidney cancer after EU regulators expanded the drug’s approved indications.