FDA Oncology Announcements

Anti-PD-1 × Dermatologic × Clear all

22 Announcements

FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma

Drug: Libtayo (cemiplimab-rwlc) · Anti-PD-1 antibody
Condition: Dermatologic

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 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 nivolumab for adjuvant treatment of Stage IIB/C melanoma

Trial: CheckMate76K
Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma

Drug: Zynyz (retifanlimab-dlwr) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves pembrolizumab for adjuvant treatment of Stage IIB or IIC melanoma

Trial: KEYNOTE-716
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

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 cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma

Drug: cemiplimab-rwlc · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves pembrolizumab for cutaneous squamous cell carcinoma

Trial: MK-3475-629
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves pembrolizumab for cutaneous squamous cell carcinoma

Trial: MK-3475-629
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

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 adults and children with TMB-H solid tumors

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

FDA approves new dosing regimen for pembrolizumab

Trial: KEYNOTE-555
Drugs: KEYTRUDA (400 mg every six weeks for pembrolizumab) , KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves pembrolizumab for adjuvant treatment of melanoma

Trial: MK-3475-054
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves pembrolizumab for Merkel cell carcinoma

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves cemiplimab-rwlc for metastatic or locally advanced cutaneous squamous cell carcinoma

Drug: LIBTAYO (cemiplimab-rwlc) · Anti-PD-1 antibody
Condition: Dermatologic

FDA grants regular approval to nivolumab for adjuvant treatment of melanoma

Trial: CheckMate 238
Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Condition: Dermatologic

Pembrolizumab label updated with new clinical trial information

Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

Nivolumab in combination with ipilimumab

Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, ipilimumab · Anti-CTLA-4 antibody
Condition: Dermatologic

Nivolumab (Opdivo)

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Conditions: DermatologicThoracic

Nivolumab

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Condition: Dermatologic

Pembrolizumab

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic