FDA Oncology Announcements

Anti-PD-1 × Thoracic × Clear all

28 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 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 neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer

Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Thoracic

FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma

Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, pemetrexed · Antifolate
Conditions: Other solid neoplasmThoracic

FDA approves neoadjuvant/ adjuvant pembrolizumab for resectable non-small cell lung cancer

Trial: MK-3475-671
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Thoracic

FDA approves pembrolizumab as adjuvant treatment for non-small cell lung cancer

Trial: PEARLS
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Thoracic

FDA approves cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancer

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

FDA approves neoadjuvant nivolumab and platinum-doublet chemotherapy for early-stage non-small cell lung cancer

Trial: CheckMate 816
Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Thoracic

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 non-small cell lung cancer with high PD-L1 expression

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

FDA approves nivolumab and ipilimumab for unresectable malignant pleural mesothelioma

Trial: CheckMate743
Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Conditions: Other solid neoplasmThoracic

FDA approves nivolumab and ipilimumab for unresectable malignant pleural mesothelioma

Trial: CheckMate743
Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Conditions: Other solid neoplasmThoracic

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 nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC

Trial: CheckMate 9LA
Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Condition: Thoracic

FDA approves nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC

Trial: CheckMate 9LA
Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Condition: Thoracic

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

Trial: CheckMate 227
Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Condition: Thoracic

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

Trial: CheckMate 227
Drugs: OPDIVO (nivolumab) · Anti-PD-1 antibody, YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Condition: Thoracic

FDA approves pembrolizumab for metastatic small cell lung cancer

Trial: MK-3475-028
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Thoracic

FDA expands pembrolizumab indication for first-line treatment of NSCLC (TPS ≥1%)

Trial: Keynote 042
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Thoracic

FDA approves pembrolizumab in combination with chemotherapy for first-line treatment of metastatic squamous NSCLC

Trial: KEYNOTE-407
Drugs: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody, carboplatin · Platinum agent
Condition: Thoracic

FDA grants regular approval for pembrolizumab in combination with chemotherapy for first-line treatment of metastatic nonsquamous NSCLC

Trial: MK-3475-189
Drugs: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody, pemetrexed · Antifolate
Condition: Thoracic

FDA grants nivolumab accelerated approval for third-line treatment of metastatic small cell lung cancer

Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Thoracic

Pembrolizumab (Keytruda) 5-10-2017

Drugs: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody, pemetrexed · Antifolate, carboplatin · Platinum agent
Condition: Thoracic

Pembrolizumab (KEYTRUDA) Checkpoint Inhibitor

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

Nivolumab Injection

Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Thoracic

Pembrolizumab injection

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

Nivolumab (Opdivo)

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