Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that its licensing partner Specialised Therapeutics Asia (STA) has received marketing approval of NERLYNX® (neratinib) in Malaysia from the Drug Control Agency (DCA), under Malaysia’s Ministry of Health (MOH). NERLYNX is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy.

...Knight Therapeutics Inc. (TSX:GUD) ("Knight"), a leading Canadian specialty pharmaceutical company, announced today that Health Canada has approved NERLYNX® (neratinib) for the extended adjuvant treatment of women with early-stage hormone receptor positive, HER2-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy.

Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.

After a median follow-up of 5·2 years (IQR 2·1-5·3), patients in the neratinib group had significantly fewer invasive disease-free survival events than those in the placebo group (116 vs 163 events; stratified hazard ratio 0·73, 95% CI 0·57-0·92, p=0·0083).

...Age will be assessed in years = neratinib initiation date - date of birth`Description of age`Gender will be described in percentage of Male and Female among patients`Description of Gender`BMI will be assessed in kg/m2`Description of BMI`Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea`Menopausal status`Comorbidities will be described in number and percentage of patients with at least one relevant comorbidity`Comorbidities`HER2 overexpression/amplification testing will be assessed by Immunohistochemistry (IHC), Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH)`HER2 overexpression/amplification testing`Hormone receptor status will be described in percentage of patients with Estrogen receptor (ER) positive, Progesterone receptor (PR) positive, ER and PR negative`Hormone receptor status`Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer`Primary tumor location`Primary tumor histology will be described in percentage of patients with Infiltrating ductal carcinoma, Infiltrating lobular carcinoma, Invasive carcinoma, Tubular, Other`Primary tumor histology`Histological grade will be described in percentage of patients with G1 Well differentiated, G2 Moderately differentiated, G3 Poorly differentiated, G4 Undifferentiated`Histological grade`Pathologic stage (AJCC classification) of Breast Cancer will be described in percentage of patients with stages 1, 2A, 2B, 3A, 3B, 3C`Pathologic stage (AJCC classification) of Breast Cancer...

...- Participants must have documented HER2+ disease by overexpression and/or gene amplification on the most recent biopsy, per current ASCO-CAP (American Society of Clinical Oncology...

...- Hormone receptor (HR) positive, Human epidermal growth factor receptor 2 (HER2) overexpressing/amplified breast cancer stage I-III;...

The overall response rate among efficacy-evaluable patients from Asia was 66.4% (180 patients) and the clinical benefit rate was 72.0% (195 patients).