Novartis considers its Kisqali to be among a dozen new medicines with blockbuster potential.
A European Medicines Agency (EMA) panel recommended on Friday approving Novartis's Kisqali drug, bolstering the Swiss drug maker's bid to challenge rival Pfizer's Ibrance against tough-to-treat breast cancer.
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 blessing in March.
This latest CHMP opinion sets the stage for likely European Commission approval this year.
Friday's announcement, while expected, underscores Novartis's push to strengthen an oncology portfolio hurt last year by the patent expiration on blood cancer drug Glivec, exposing what was once its top-selling medicine to growing generic competition.
The recommendation is also the latest in a wave of upbeat news on the Basel-based drug maker whose CEO, Joe Jimenez, has pledged to restore growth in 2018.
In recent weeks, Novartis has released positive data on cancer cell therapy CTL019, its eye drug RTH258 and Thursday's surprise announcement that anti-inflammatory canakinumab benefited heart attack survivors.
Novartis also won a US Supreme Court ruling this month that will speed its biosimilar copies of other name-brand drugs to market.
Novartis considers Kisqali to be among a dozen new medicines with blockbuster potential.
Analysts see global annual sales reaching $1.5 billion by 2022.
Its shares fell about 0.9 percent by midday after hitting a 17-month high on Thursday.
Kisqali block enzymes known as cyclin-dependent kinases 4 and 6.
It is designed for use in combination with existing drugs in women whose tumours grow in response to oestrogen and whose cancer is not caused by the HER2 protein.
Still, some analysts have expressed concern that additional patient monitoring required by the FDA on concern over heart and liver problems linked to Kisqali could dent uptake.