Tags : HER2-Positive


Tanvex Reports Results of TX05 (biosimilar, trastuzumab) in P-III Study

Shots: The P-III study evaluates the efficacy and safety of TX05 vs Herceptin (trastuzumab) in patients with human epidermal growth factor receptor 2-positive early breast cancer The 1EPs was an assessment of pCR following neoadjuvant therapy and definitive surgery in the per-protocol population Results: Patients achieved pCR (48.8% vs 45.3%) in the per-protocol population Click […]Read More

Biotech Regulatory

Chugai’s Kadcyla (trastuzumab emtansine) Receives MHLW’s Approval for Adjuvant Therapy

Shots: The approval is based on P-III KATHERINE study assessing Kadcyla (100/160mg, IV) adjuvant therapy in 1486 patients with HER2+ early BC who did not have pathologic complete response following neoadjuvant therapy including Herceptin The results showed the superiority of Kadcyla over Herceptin in terms of the 1EPs of invasive disease-free survival. The safety profile […]Read More

Biosimilars Regulatory

Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval

Shots: The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of Zercepac (HLX02) vs Herceptin Zercepac is developed under NMPA and EMA biosimilar guidelines and has been evaluated with the reference trastuzumab including comparative quality studies, preclinical studies, a P-I clinical study and […]Read More


AstraZeneca and Daiichi Sankyo Provide Updates of Enhertu (fam-trastuzumab deruxtecan-nxki)

Shots: The two companies divulged the results of ongoing P-II DESTINY-CRC01 study assessing Enhertu in patients with HER2+ unresectable and/or m-colorectal cancer, prior treated with 2L standard therapies. Results: ORR (45.3%); DCR (83.0%); PFS (6.9mos.); subgroup patients including patients with treated with a prior anti-HER2 regimen, ORR (43.8%) with a median treatment duration of 4.8mos. […]Read More

Biosimilars Regulatory

Biocon and Mylan’s Ogivri (trastuzumab, biosimilar) Receives Health Canada’s Approval

Shots: The approval is based on study assessing Ogivri vs Herceptin (trastuzumab) in patients evaluating its safety, efficacy, PK and immunogenicity The study resulted with no clinical difference in safety, efficacy and potency between Ogivri and Herceptin Ogivri (trastuzumab, biosimilar) is a mAb, currently approved in 65 countries including the US. Ogivri is one of […]Read More


Roche’s Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) Receives FDA’s Approval for

Shots: The approval is based on three P-III study (HannaH, SafeHER, PrefHER) results assessing Herceptin Hylecta (SC) + CT vs Herceptin (IV) + CT in neoadjuvant and adjuvant patients with HER2-positive early breast cancer P-III HannaH, SafeHER, PrefHER study: pCR (absence of invasive cancer cells in breast) (45.4% vs 40.7%); mean level of trastuzumab (78.7mcg/ml […]Read More


Puma Biotechnology Reports Results of Neratinib (PB272) in P-III NALA

Shots: The P-III NALA Trial involves assessing of Neratinib + capecitabine vs Tykerb (lapatinib) + capecitabine in 621 patients in ratio (1:1) with HER2-Positive Metastatic Breast Cancer The P-III NALA Trial demonstrated improvement in PFS by 1% and OS by 4% with safety profile consistent with previous trials Neratinib is an irreversible tyrosine kinase inhibitor, or TKI used for blocking signal […]Read More