- US-based biopharmaceutical company Puma biotechnology, Inc.'s (NASDAQ: PBYI) licensing partner Specialised Therapeutics Asia has received marketing authorization from Australia's Therapeutic Goods Administration to commercialise Nerlynx (neratinib) in Australia for the extended adjuvant treatment
of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab based therapy, the company said.
Healthcare solutions company Novartis reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment
of patients with melanoma with BRAF V600E or V600K mutation.
M2 PHARMA-February 5, 2019-Genentech Submits Supplemental Biologics License Application to FDA for Kadcyla for Adjuvant Treatment
of People with HER2-Positive Early Breast Cancer with Residual Disease After Neoadjuvant Treatment
Genentech, a member of the Roche Group, announced the Phase III KATHERINE study met its primary endpoint, showing Kadcyla as a single agent significantly reduced the risk of disease recurrence or death compared to Herceptin as an adjuvant treatment
in people with HER2-positive early breast cancer, or EBC, who have residual disease present following neoadjuvant treatment.
The US Food and Drug Administration (FDA) approved neratinib in July 2017 for the extended adjuvant treatment
of adult patients with early stage HER2-positive breast cancer, following adjuvant trastuzumab-based therapy.
- The US Food and Drug Administration has approved Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceoptin 1 (trastuzumab), across all eligible indications, namely adjuvant treatment
of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease, Korean biopharmaceutical company Samsung Bioepis Co said.
Genentech announced the Phase III Katherine study met its primary endpoint, showing Kadcyla as a single agent reduced the risk of disease recurrence or death compared to Herceptin as an adjuvant treatment
in people with HER2-positive early breast cancer who have residual disease present following neoadjuvant treatment.
The approval from the US FDA is for Perjeta in combination with Herceptin (trastuzumab) and chemotherapy for adjuvant treatment
of HER2-positive eBC at high risk of recurrence.
Healthcare company Pfizer Inc reported on Thursday the receipt of approval from the US Food and Drug Administration for Sutent (sunitinib malate) for the adjuvant treatment
of adult patients who are at a high risk of kidney cancer (renal cell carcinoma) returning after a kidney has been removed (nephrectomy).
The largest adjuvant treatment
breast cancer trial to date, TAILORx involved 10,273 women across 1,100 trial sites in six participating countries.
The product is intended for the adjuvant treatment
of patients with stage III melanoma with a BRAF V600 mutation after complete resection.
M2 PHARMA-December 11, 2018-Puma Biotechnology Presents Results of Patient Reported Outcomes in Phase II CONTROL Trial of Neratinib in Extended Adjuvant Treatment
of HER2-Positive Early Stage Breast Cancer