Neratinib (also called Nerlynx and marketed by Pierre Fabre) is recommended, under the terms of a commercial arrangement, for people with this type of breast cancer who are less than 1 year from completing trastuzumab
(Herceptin)-based treatment following surgery (called adjuvant treatment).
Health Canada approval was based on the Phase III ExteNET trial, a multicenter, randomised, double-blind, placebo-controlled trial of neratinib following adjuvant trastuzumab
Reportedly, Health Canada's approval was based on the phase III ExteNET trial, a multicentre, randomised, double-blind, placebo-controlled trial of neratinib following adjuvant trastuzumab
Food and Drug Administration (FDA) has approved KANJINTI[TM] (trastuzumab-anns) for all approved indications of the reference product, Herceptin[R] (trastuzumab
): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Christiane Hamacher, chief executive officer of Biocon Biologies, said: "The final safety and overall survival data from the HERITAGE study for our biosimilar trastuzumab
, Ogivri, cumulative through 36 months of follow-up, reconfirms that efficacy and safety is very similar to the reference product, Herceptin.
Sellas Life Sciences announced results from a preplanned analysis of immunologic responses in the cohort of patients with triple negative breast cancer, or TNBC, from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial of nelipepimut-S, or NPS, +/- trastuzumab
targeting HER2 low-expressing breast cancer patients.
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced positive top-line results for the pivotal Phase II DESTINY-Breast01 trial of trastuzumab
- Collaboration combines Daiichi Sankyo's scientific and technological excellence with AstraZeneca's global experience and resources in oncology to accelerate and expand the potential of [fam-] trastuzumab
deruxtecan as monotherapy and combination therapy across a spectrum of HER2 expressing cancers
Food and Drug Administration (FDA) has approved Herceptin Hylecta (trastuzumab
and hyaluronidase-oysk) for subcutaneous (under the skin) injection for the treatment of certain people with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease.
'In the era before Trastuzumab
, HER2-positive breast cancer was a subgroup that had the worst prognosis,' Dr.
Daiichi Sankyo has entered into a clinical trial collaboration agreement with Merck KGaA and Pfizer to evaluate the combination of [fam-] trastuzumab
deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), in combination with the checkpoint inhibitor avelumab and/or an investigational Merck KGaA DNA damage response (DDR) inhibitor, in patients with HER2 expressing or mutated solid tumors.