FDA Oncology Announcements

Pyrimidine analog × Clear all

9 Announcements

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer

Trial: SunRISe-1
Drug: Inlexzo (gemcitabine intravesical system) · Pyrimidine analog
Condition: Genitourinary

FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma

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

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 nivolumab in combination with cisplatin and gemcitabine for unresectable or metastatic urothelial carcinoma

Trial: CheckMate901
Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, cisplatin · Platinum agent, gemcitabine · Pyrimidine analog
Condition: Genitourinary

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 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 Gemtuzumab Ozogamicin for CD33-positive AML

Drugs: Mylotarg (gemtuzumab ozogamicin) · Anti-CD33 antibody-drug conjugate, daunorubicin · Anthracycline, cytarabine · Pyrimidine analog
Condition: Myeloid

Necitumumab

Drugs: PORTRAZZA (necitumumab) · Anti-EGFR antibody, gemcitabine · Pyrimidine analog, cisplatin · Platinum agent
Condition: Thoracic

FDA approves gemcitabine (Gemzar, Eli Lilly and Company)

Drugs: Gemzar (gemcitabine) · Pyrimidine analog, carboplatin · Platinum agent
Condition: Gynecologic