New breast cancer drug approved by the Philippines’ Food and Drug Administration

A new drug shown to significantly reduce the risk of cancer recurrence or death in an aggressive form of breast cancer has been approved by the Food and Drug Administration of the Philippines.

The drug, NERLYNX (neratinib) is an oral medication taken daily for 12 months by women who have been diagnosed with early-stage HER2-positive (HER2+) breast cancer and who have received prior trastuzumab-based therapy.

It has been approved by the Food and Drug Administration of the Philippines “for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.”

The greatest benefit is seen in women who are hormone-receptor positive (HR+) and who initiate NERLYNX therapy within 12 months of completing trastuzumab-based therapy. Their five-year risk of recurrence is reduced by 42% after completing 12 months of NERLYNX therapy.

Chair of the Philippines’ Cardinal Santos Medical Center, Dr Ma. Luisa Abesamis-Tiambeng, said the NERLYNX approval was “a great step forward” for women in the Philippines who have been diagnosed with early breast cancer that is both HER2+ and HR+.

Dr Tiambeng commented: “We know that one in four women with this type of breast cancer are still at risk of recurrence, despite treatment with chemotherapy and trastuzumab-based therapy following their initial breast surgery. Following this important approval by the Food and Drug Administration of the Philippines, NERLYNX presents a new opportunity for women in this region to have extended adjuvant therapy to further reduce their chance of a relapse.”

NERLYNX is being made available by independent pharmaceutical company, Specialised Therapeutics (ST).

ST Chief Executive Officer Carlo Montagner said NERLYNX was the first therapy in the company’s therapeutic portfolio to achieve approval in the Philippines.

“There are regulatory nuances in every territory in which we operate, and this latest approval is a testament to the skill of our regulatory team, who are navigating complex jurisdictions,” he said.

“From a patient perspective, this is the first time the women in the Philippines are being presented with an opportunity for extended-adjuvant therapy that will reduce the risk of disease recurrence.

“We are pleased to be at the forefront of this new treatment paradigm and look forward to changing outcomes for these women and their families and friends.”

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