Posted by Michael Wonder on 03 Dec 2019
Puma Biotechnology licensing partner Specialised Therapeutics receives marketing approval in Singapore for Nerlynx (neratinib) for extended adjuvant treatment of early stage hormone receptor positive HER2-positive breast cancer
2 December 2019 - Puma Biotechnology announced that its licensing partner Specialised Therapeutics Asia has received marketing approval of Nerlynx (neratinib) in Singapore from the Health Sciences Authority, a statutory board under the Ministry of Health of the Singapore Government.
Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.
Specialised Therapeutics Asia Chief Executive Officer Carlo Montagner said, “The approval in Singapore is a key milestone for the company as Nerlynx is the first drug in our portfolio to be approved by the HSA for commercialisation in Singapore. We look forward to extending the reach of this medicine, with regulatory dossiers also submitted in Malaysia, Brunei and the Philippines."
