European authorities approve cancer drugs

Organisation: Position: Deadline Date: Location:

A European Medicines Agency (EMA) panel has recommended approving Novartis’s Kisqali drug, bolstering the Swiss drugmaker’s bid to challenge rival Pfizer’s Ibrance against tough-to-treat breast cancer.

Reuters Health reports that the EMA’s Committee for Medicinal Products for Human Use (CHMP) backed Kisqali in combination with hormone therapy as a first-line treatment for hormone receptor positive, human epidermal growth factor receptor-2 negative locally advanced or metastatic breast cancer.

Kisqali got the US Food and Drug Administration’s (FDA’s) blessing in March. The report says this latest CHMP opinion sets the stage for likely European Commission approval in the next few months.


US health regulators have, meanwhile, approved a new formulation of Roche’s big-selling cancer drug Rituxan for three common types of blood cancers that allows for relatively quick administration via injection under the skin in place of a lengthy intravenous infusion.

Reuters Health reports that the new formulation, to be sold under the name Rituxan Hycela, combines the medicine with an enzyme that can deliver the active ingredient with a subcutaneous injection in five to seven minutes compared with an infusion that typically takes 90 minutes or longer.

The FDA approved Rituxan Hycela to treat adults with follicular lymphoma, diffuse large B-cell lymphoma or chronic lymphocytic leukaemia, Roche’s Genentech unit said.

The report says the FDA approval is based on clinical studies that demonstrated that subcutaneous administration of Rituxan Hycela resulted in similar levels of the antibody in the blood with comparable clinical efficacy compared with intravenous Rituxan.

The new formulation will be available to US patients in one to two weeks, the company said. Regular IV Rituxan will also still be available.

The report says Rituxan, which is beginning to face competition from less expensive biosimilar rivals in Europe, had global sales of about $7.5bn in 2016.

Reuters Health report
Reuters Health report

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