FDA Oncology Announcements

Anti-PD-L1 × Clear all

28 Announcements

FDA approves durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma

Drugs: Imfinzi (durvalumab) · Anti-PD-L1 antibody, fluorouracil · Fluoropyrimidine
Condition: Gastrointestinal

FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer

Trial: IMforte
Drugs: Zepzelca (lurbinectedin) · Alkylating agent, Tecentriq (atezolizumab) · Anti-PD-L1 antibody, Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) · Anti-PD-L1 antibody
Condition: Thoracic

FDA approves durvalumab for muscle invasive bladder cancer

Trial: NIAGARA
Drugs: Imfinzi (durvalumab) · Anti-PD-L1 antibody, gemcitabine · Pyrimidine analog, cisplatin · Platinum agent
Condition: Genitourinary

FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma

Drug: Unloxcyt (cosibelimab-ipdl) · Anti-PD-L1 antibody
Condition: Dermatologic

FDA approves durvalumab for limited-stage small cell lung cancer

Trial: ADRIATIC
Drug: Imfinzi (durvalumab) · Anti-PD-L1 antibody
Condition: Thoracic

FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection

Drug: Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) · Anti-PD-L1 antibody

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

Trial: AEGEAN
Drug: Imfinzi (durvalumab) · Anti-PD-L1 antibody
Condition: Thoracic

FDA approves durvalumab with chemotherapy for mismatch repair deficient primary advanced or recurrent endometrial cancer

Trial: DUO-E
Drug: Imfinzi (durvalumab) · Anti-PD-L1 antibody
Conditions: GynecologicOther solid neoplasm

FDA grants approval to atezolizumab for alveolar soft part sarcoma

Drug: Tecentriq (atezolizumab) · Anti-PD-L1 antibody
Condition: Sarcoma

FDA approves tremelimumab in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancer

Trial: POSEIDON
Drugs: Imjudo (tremelimumab) · Anti-CTLA-4 antibody, Imfinzi (durvalumab) · Anti-PD-L1 antibody
Condition: Thoracic

FDA approves tremelimumab in combination with durvalumab for unresectable hepatocellular carcinoma

Trial: HIMALAYA
Drugs: Imjudo (tremelimumab) · Anti-CTLA-4 antibody, durvalumab · Anti-PD-L1 antibody
Condition: Gastrointestinal

FDA approves durvalumab for locally advanced or metastatic biliary tract cancer

Trial: TOPAZ-1
Drugs: Imfinzi (durvalumab) · Anti-PD-L1 antibody, gemcitabine · Pyrimidine analog, cisplatin · Platinum agent
Condition: Gastrointestinal

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

Drug: Tecentriq (atezolizumab) · Anti-PD-L1 antibody
Condition: Thoracic

FDA approves atezolizumab for BRAF V600 unresectable or metastatic melanoma

Drugs: Tecentriq (atezolizumab) · Anti-PD-L1 antibody, cobimetinib · MEK inhibitor, vemurafenib · BRAF inhibitor
Condition: Dermatologic

FDA approves avelumab for urothelial carcinoma maintenance treatment

Trial: JAVELIN Bladder 100
Drug: BAVENCIO (avelumab) · Anti-PD-L1 antibody
Condition: Genitourinary

FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma

Trial: IMbrave150
Drugs: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody, AVASTIN (bevacizumab) · Anti-VEGFR antibody
Condition: Gastrointestinal

FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression

Drug: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody
Condition: Thoracic

FDA approves durvalumab for extensive-stage small cell lung cancer

Trial: CASPIAN
Drugs: IMFINZI (durvalumab) · Anti-PD-L1 antibody, etoposide · Topoisomerase II inhibitor
Condition: Thoracic

FDA approves atezolizumab with nab-paclitaxel and carboplatin for metastatic NSCLC without EGFR/ALK aberrations

Trial: IMpower130
Drugs: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody, paclitaxel protein-bound · Taxane, carboplatin · Platinum agent
Condition: Thoracic

FDA approves avelumab plus axitinib for renal cell carcinoma

Trial: JAVELIN Renal 101
Drugs: BAVENCIO (avelumab) · Anti-PD-L1 antibody, axitinib · VEGFR inhibitor
Condition: Genitourinary

FDA approves atezolizumab for extensive-stage small cell lung cancer

Trial: IMpower133
Drugs: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody, carboplatin · Platinum agent, etoposide · Topoisomerase II inhibitor
Condition: Thoracic

FDA approves atezolizumab for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer

Drugs: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody, paclitaxel protein-bound · Taxane
Condition: Breast

Atezolizumab (TECENTRIQ)

Drug: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody

FDA approves durvalumab after chemoradiation for unresectable stage III NSCLC

Trial: PACIFIC
Drug: Imfinzi (durvalumab) · Anti-PD-L1 antibody
Condition: Thoracic

FDA grants accelerated approval to avelumab for urothelial carcinoma

Drug: BAVENCIO (avelumab) · Anti-PD-L1 antibody
Condition: Genitourinary

Durvalumab (Imfinzi)

Drug: IMFINZI (durvalumab) · Anti-PD-L1 antibody

Atezolizumab (TECENTRIQ)

Drug: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody

Atezolizumab for Urothelial Carcinoma

Drug: Tecentriq (atezolizumab) · Anti-PD-L1 antibody
Condition: Genitourinary