Tags : (trastuzumab emtansine)

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

Roche’s Kadcyla (trastuzumab emtansine) Receives Health Canada’s Approval for The

Shots: The approval is based on P-III KATHERINE study assessing Kadcyla vs Herceptin as adjuvant therapy in people with HER2+ eBC with pathological residual invasive disease in the breast and/or axillary lymph nodes following neoadjuvant taxane and Herceptin-based treatment The P-III KATHERINE study results: reduction in the risk of residual invasive BC recurrence or death […]Read More

Roche’s Kadcyla (trastuzumab emtansine) Receives CHMP’s Recommendation for Approval as

Shots: The CHMP’s recommendation is based on P-III KATHERINE study assessing Kadcyla vs Herceptin as an adjuvant therapy in patients with HER2+ early breast cancer with the residual invasive disease after neoadjuvant treatment which included Herceptin and Taxane-based CT The P-III KATHERINE study results: reduction in iDFS by 50%; @3yrs. iDFS (88.3% vs 77.0%) showing […]Read More

Chugai Files an Application to MHLW for an Additional Indication

Shots: The application is based on P-III KATHERINE study assessing Kadcyla as adjuvant therapy vs Herceptin in ~ 1,500 patients with HER2+ early breast cancer who had invasive residual disease in the breast or axillary lymph nodes following neoadjuvant therapy including Herceptin The P-III KATHERINE study results: superiority in invasive disease-free survival as confirmed; no […]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

Roche Reports Results of Kadcyla (trastuzumab emtansine) in P-III KATHERINE

Shots: The P-III KATHERINE study assessed Kadcyla vs Herceptin (trastuzumab) as an adjuvant therapy for patients with HER2-positive eBC for three years P-III KATHERINE study results: risk of disease recurrence or death 50%; didn’t have breast cancer return (88.3% vs 77.0%); with no new safety issues Kadcyla is an antibody-drug conjugate (ADC) developed for delivering […]Read More