Novartis cancer drug gets Phl FDA approval

MANILA, Philippines - The Novartis anti-cancer drug everolimus, in combination with aromatase inhibitor, is now approved in the Philippines for the treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced breast cancer, in postmenopausal women after recurrence or progression following endocrine therapy.

“Everolimus represents the first major innovation in HR+/HER2- advanced breast cancer since aromatase inhibitors were introduced more than 15 years ago,” said Thomas Weigold, country president and managing director of Novartis Healthcare Philippines.

“The Philippine FDA’s approval of everolimus provides an important new treatment option for Filipino women living with this disease,” said Bibiane Fontejon, Oncology Business Unit head of Novartis Healthcare Philippines.

The Food and Drug Administration (FDA) approved the new indication based on the recommendations of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

The European Commission generally follows the recommendations of the CHMP and usually delivers its final decision within three months of the CHMP recommendation.

The decision will be applicable to all 27 European Union member-states plus Iceland and Norway.

Everolimus is a novel drug that offers a new approach to cancer treatment by continuously targeting mTOR, a protein that acts as a central regulator of cancer cell division, cell metabolism and blood vessel growth.

“mTOR is like a switch that activates cancer cells to divide and grow. Everolimus turns off this switch,” said Dr. Joseph Tovera, oncology medical director of Novartis Healthcare Philippines.

The once-daily tablet everolimus is also approved by the Philippine FDA for the treatment of adult patients with advanced renal cell carcinoma (RCC, the most common type of kidney cancer) whose disease has progressed on or after treatment with another targeted therapy, anti VEGF-TKI therapy, as well as adult patients with advanced neuroendocrine tumors (NET) of gastrointestinal, lung or pancreatic origin.

Anti-VEGF therapy specifically inhibits the ability of cancer cells to stimulate the growth of new blood vessels (angiogenesis); without an adequate blood supply, cancer cells are unable to grow and spread (metastasize) and eventually die.

Unlike other therapies that primarily inhibit tumor angiogenesis, everolimus directly inhibits mTOR resulting in reduced tumor cell growth and proliferation, decreased tumor angiogenesis, and inhibited cell metabolism.

Everolimus is now approved by the US Food and Drug Administration, the Swiss Agency for Therapeutic Products (Swissmedic) and by health authorities worldwide.

It is also being studied in HER2-positive breast cancer in two Phase III trials.