Tags : Metastatic

BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health

Shots: The approval is based on P-III CheckMate -9LA study assessing Opdivo + Yervoy combined with two cycles of platinum-doublet CT vs CT (four cycles followed by optional pemetrexed maintenance therapy if eligible) as a 1L treatment in patients with metastatic/ recurrent NSCLC regardless of PD-L1 expression and histology The study met its 1EPs & […]Read More

Samsung Bioepis Launches Ontruzant (trastuzumab, biosimilar) for Early and Metastatic

Shots: The company launches its first oncology treatment Ontruzant (trastuzumab), a biosimilar referencing Herceptin in Brazil. The biosimilar has received ANVISA’s approval for the treatment of metastatic HER2-overexpressing BC, early HER2-overexpressing BC, and advanced gastric cancer Ontruzant is being supplied to SUS through a PDP b/w Samsung Bioepis & Bionovis and Bio-Manguinhos. This the second […]Read More

Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced/

Shots: Oncorus has initiated a P-I study assessing ONCR-177 as monothx. and in combination with Merck’s Keytruda in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors The P-I study enrolls ~21 cancer patients while P-II study enrolls patients to histology- specific expansion cohorts. The P-I study will evaluate the safety and […]Read More

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

Merck’s Keytruda Receives the NMPA’s Approval as a 2L Treatment

Shots: The approval is based on P-III KEYNOTE-181 study assessing Keytruda vs CT in previously treated patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10) and  data from an extension of the global study in Chinese patients Results: Median OS (10.3 vs 6.7mos.), in Chinese patients: median OS (12.0 vs 5.4mos.). With […]Read More