The US Food and Drug Administration (FDA) has approved Novartis’ new drug Kisqali (ribociclib) as an initial treatment for postmenopausal women with a type of metastatic breast cancer known as HR+/HER2-.The regulatory authority acknowledged that the kinase inhibitor has been shown to slow the progress of the disease by blocking two proteins that can stimulate growth and division of cancer cells.

In a four-week regime, Kisqali – which was developed by the Swiss drugmaker in cooperation with Astex Pharmaceuticals, a subsidiary of Japan's Otsuka Group – is taken for three weeks followed by a one-week break. Parallel to this, patients also take either letrozole, an older cancer drug, or another aromatase inhibitor over the entire four-week cycle.

A four-week treatment with Kisqali in the US will cost $10,950 for the strongest dose of 600 mg, with the price decreasing parallel to the strength of the dose. Novartis said it will offer patients financial assistance to pay for the treatment, and depending on arrangements with health insurers, they may be able to forego copayments. This is an important therapy for those who have limited options, it said.

The company is currently conducting additional studies for treatments with Kisqali in combination with other treatments and in pre-menopausal women. It said two are late-stage studies, with results expected to be published in late 2017 or early 2018.

In an earlier study with 668 women funded by Novartis, the drugmaker said it found that Kisqali and letrozole together reduced the risk of death or the cancer worsening by 44%, compared with those receiving only letrozole. Kisqali can have serious side effects, ranging from potentially fatal abnormal heartbeat, serious liver problems and severe infections.

In similar oncology news, US drugmaker Eli Lilly said a combination of its experimental breast cancer drug abemaciclib and another widely used treatment was shown to slow disease progression in a key study involving patients who had relapsed or did not derive enough benefit from anti-estrogen therapy.  It is also conducting trials comparing the use abemaciclib in combination with other treatments.

Abemaciclib, for which the FDA granted  breakthrough therapy status for breast cancer in 2015, is also being tested for use in lung cancer. Lilly said it plans to submit an application to market th drug as a monotherapy in this year’s  second quarter and as a combination therapy in the third quarter.