FDA Oncology Announcements

Anti-PD-1 × Head & Neck × Clear all

11 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 approves neoadjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma

Trial: MK-3475-689
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Head & Neck

FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma

Drugs: penpulimab-kcqx · Anti-PD-1 antibody, gemcitabine · Pyrimidine analog
Condition: Head & Neck

FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection

Trial: CheckMate-67T
Drugs: Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) · Anti-PD-1 antibody, Opdivo (nivolumab) · Anti-PD-1 antibody
Conditions: DermatologicGastrointestinalGenitourinaryHead & NeckThoracic

FDA approves toripalimab-tpzi for nasopharyngeal carcinoma

Drugs: LOQTORZ (toripalimab-tpzi) · Anti-PD-1 antibody, cisplatin · Platinum agent, gemcitabine · Pyrimidine analog
Condition: Head & Neck

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 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

FDA approves pembrolizumab for first-line treatment of head and neck squamous cell carcinoma

Trial: MK-3475-048
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Head & Neck

Nivolumab for SCCHN

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Condition: Head & Neck

pembrolizumab (KEYTRUDA)

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Head & Neck