ibusinesslines.com March 24, 2017

Novartis Kisqali Gets FDA Approval To Treat HR+/HER2- Metastatic Breast Cancer

20 March 2017, 05:12 | Melissa Porter

FDA OKs Novartis' ribociclib for first-line treatment of certain type of breast cancer

Kisqali Novartis Astex Pharmaceuticals mechanism of action

The FDA has approved ribociclib (Kisqali, Novartis) in combination with the aromatase inhibitor letrozole (Femara, Novartis) as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. According to the American Cancer Society, about 40 percent of USA women diagnosed with breast cancer have this type.

In the course of the four weeks, patients are also given letrozole, which can be substituted for another aromatase inhibitor, contingent on the aspects of their condition.

"A once-daily oral dose of Kisqali plus letrozole reduced the risk of disease progression or death by 44 percent over letrozole alone, according to results of a study released previous year".

Kisqali, part of the drug class called kinase inhibitors, is taken daily for three weeks, followed by a one-week break. These results were monitored in comparison with patients treated only with letrozole. More than half of patients administered ribociclib plus letrozole remained alive and progression free at the time of interim analysis, therefore median PFS could not be determined. It can not be taken by women who are pregnant or breastfeeding.

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

Novartis is looking to quickly ramp up Kisqali's approved indications to take the fight to Ibrance. Regulators recommend patients receive ECG monitoring before starting up treatment with Kisqali and repeat it at day 14 of the first cycle and the beginning of the second cycle. In a move likely meant to counter that disadvantage, Novartis is jumping into the market with what it says will be an 18 percent to 20 percent lower aggregate cost based on the dosing seen in the trial.

Novartis said a pack of 21 pills of Kisqali, a four-week supply, will have a list price of $10,950 for the 600-milligram dose.

Novartis has always been a leader in developing cancer medicines. A longer-term forecast based on six analysts' models suggests worldwide sales of the therapy could reach $1.45 billion by 2022.

The drug, also known as ribociclib, hits the market as Kisqali with peak sales estimates of around $2.5 billion a year, giving the pharma giant a clear shot at a new blockbuster franchise.

Novartis is conducting additional Kisqali studies in combination with other treatments to judge its effectiveness in those groupings.

Two are late-stage studies, usually the last stage before seeking regulatory approval, and results should be available late this year or early next year, the company said. But the company said that most health issues that arose during Kisqali's trials were mild to moderate and generally managed through interrupting or reducing the dose.

Other News

Trending Now

Chase Involving U-Haul Ends In Fiery Crash In Revere
Saugus Police said they're also investigating another nearby break-in in connection to the incident. Police say the chase began shortly thereafter when officers saw the UHaul on Walnut Street.

Suspect Caught in New Mexico
Kelsey Begaye, President of the Navajo Nation, said Largo's death is a reminder of the unsafe situations officers often face. His bullet-proof vest stopped one shot to his abdomen, but he suffered a gunshot wound to the forehead.

Gophers Earn No. 1 Seed in NE Regional
But the Irish have had some success in Manchester , beating Merrimack and New Hampshire on their way to the 2011 Frozen Four . Minnesota and Notre Dame last met during the 2015-16 season, with both teams winning one game in a series in South Bend.

Trump budget proposes cutting home heating help to nearly 28000 NH households
The National Institutes of Health faces a $5.8 billion cut , also 18% from its current budget, to $25.9 billion in total. Trump's $54 billion (Dh198.61 billion) increase in military spending looks to be how he will justify these cuts .

Mitchell Starc misses Australia's last two Tests in India because of injury
It is expected that Starc will be available for the Champions Trophy later this year. Subsequently, he also missed the ICC World Twenty20 in India in March previous year .

Teen crashes vehicle into fence outside Trump's Mar-a-Lago
That's a bill local taxpayers will have to pay if the federal government or President Trump himself doesn't reimburse. Back in 2011, tweeting this: "The habitual vacationer, Barack Obama , is now in Hawaii.

Bodies of 2 teens found in Baltimore home after arson fire
Police say there were eight people inside the building at the time of the fire, ranging in age from 4 to 38. Smith says investigators believe that the firebombing was in retaliation for the shooting.