Tags : HER2

Daiichi Reports EMA’s Validation of MAA and Accelerated Assessment for

Shots: The MAA validation is based on P-II DESTINY-Breast01 trial assessing Trastuzumab Deruxtecan as a monothx in patients with 2L+ HER2 positive metastatic breast cancer and the results were published in the NEJM The EMA’s CHMP validation provides the application is complete and commences the scientific review process while CHMP’s accelerated assessment is granted to […]Read More

Celltrion and Teva Report Results Updated Results of CT-P6 in

Shots: The study involves assessing of CT-P6 vs reference trastuzumab in 516 patients neoadjuvant period of the study entered the adjuvant treatment period The study resulted in 9 patients (3.3%) in the biosimilar group and 6 patients (2.2%) in the reference group in the ITT population had recurrent or progressive disease @1 year. In adjuvant […]Read More

Eli Lilly Reports Results of Verzenio (abemaciclib) in P-III MONARCH

Shots: The P-III MONARCH 2 study involves assessing of Verzenio + fulvestrant vs PBO + fulvestrant in 669 pre/peri- and postmenopausal women in a ratio (2:1) with HR+, HER2- metastatic breast cancer whose cancer progressed following endocrine therapy The P-III MONARCH 2 study resulted in meetings 2EP of overall survival with no new observed safety […]Read More

Knight Therapeutics’ Nerlynx (neratinib) Receives Health Canada Approval as Extended

Shots: The marketing authorization is based on P-III ExteNET study results assessing Nerlynx following adjuvant trastuzumab therapy vs PBO in 2,840 patients with early-stage HER2-positive breast cancer within two of completing trastuzumab-based adjuvant therapy The P-III ExteNET study resulted in a 51% reduction in risk of diseases recurrence in patients @2yrs. with invasive disease-free survival […]Read More

Roche’s Kadcyla (trastuzumab emtansine) Receives FDA’s Expanded Approval as an

Shots: The approval is based on P-III KATHERINE study results assessing Kadcyla versus Herceptin in patients with HER2+ early breast cancer (eBC) with the residual invasive disease after neoadjuvant treatment included Herceptin and taxane-based CT The P-III KATHERINE study results: reduction in risk of breast cancer recurrence (50%); @3yrs. iDFS (88.3% vs 77.0%); absolute improvement […]Read More

Sandoz Signs an Agreement with EirGenix to Commercialize Proposed Trastuzumab

Shots: EirGenix to receive upfront, milestones with profit sharing on sales and will be responsible for the development & manufacturing of proposed biosimilar trastuzumab. Sandoz to get WW rights to commercialize the proposed biosimilar trastuzumab (Ex- China & Taiwan) The agreement is the third biosimilar collaboration for Sandoz in 18 months, which will further focus […]Read More

Daiichi Reports Results of [Fam-] Trastuzumab Deruxtecan (DS-8201) in P-I

Shots: The P-I study involved assessing of [Fam-] trastuzumab deruxtecan (5.4, 6.4 mg/kg) in 46 patients with heavily pretreated HER2 low expressing metastatic breast cancer P-I study results: ORR (44.2 %, 47.4%); disease control rate (79.1%, 81.6%); mDOR (9.4mos., 11.0 mos.); mPFS (7.6 mos., 7.9 mos.) [Fam-] Trastuzumab deruxtecan (DS-8201) is a HER2 targeting antibody […]Read More