FDA Oncology Announcements

Anti-PD-1 × Breast × Clear all

7 Announcements

FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection

Trial: MK-3475A-D77
Drug: Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) · Anti-PD-1 antibody
Condition: Other solid neoplasm

FDA grants accelerated approval to dostarlimab-gxly for dMMR advanced solid tumors

Drug: Jemperli (dostarlimab-gxly) · Anti-PD-1 antibody
Condition: Other solid neoplasm

FDA approves pembrolizumab for high-risk early-stage triple-negative breast cancer

Trial: MK-3475-522
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Breast

FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer

Trial: KEYNOTE-355
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Breast

FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer

Trial: KEYNOTE-355
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Breast

FDA approves pembrolizumab for adults and children with TMB-H solid tumors

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Other solid neoplasm

FDA approves pembrolizumab for adults and children with TMB-H solid tumors

Trial: KEYNOTE 158
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Other solid neoplasm