FDA Oncology Announcements

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20 Announcements

FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

Trial: KEYNOTE-B96
Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, paclitaxel · Taxane
Condition: Gynecologic

FDA approves darolutamide for metastatic castration-sensitive prostate cancer

Trial: ARASENS
Drugs: Nubeqa (darolutamide) · Second-generation nonsteroidal antiandrogen, docetaxel · Taxane
Condition: Genitourinary

FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal

Drugs: Zynyz (retifanlimab-dlwr) · Anti-PD-1 antibody, carboplatin · Platinum agent, paclitaxel · Taxane
Condition: Gastrointestinal

FDA expands endometrial cancer indication for dostarlimab-gxly with chemotherapy

Trial: RUBY
Drugs: Jemperli (dostarlimab-gxly) · Anti-PD-1 antibody, carboplatin · Platinum agent, paclitaxel · Taxane
Condition: Gynecologic

FDA approves pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma

Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, carboplatin · Platinum agent, paclitaxel · Taxane
Condition: Gynecologic

FDA approves dostarlimab-gxly with chemotherapy for endometrial cancer

Drugs: Jemperli (dostarlimab-gxly) · Anti-PD-1 antibody, carboplatin · Platinum agent, paclitaxel · Taxane
Condition: Gynecologic

FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer

Drugs: Nubeqa (darolutamide) · Second-generation nonsteroidal antiandrogen, docetaxel · Taxane
Condition: Genitourinary

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 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

FDA approves bevacizumab in combination with chemotherapy for ovarian cancer

Drugs: Avastin (bevacizumab) · Anti-VEGFR antibody, carboplatin · Platinum agent, paclitaxel · Taxane
Condition: Gynecologic

Ramucirumab (Cyramza)

Drugs: Cyramza (ramucirumab) · Anti-VEGFR antibody, docetaxel · Taxane, paclitaxel · Taxane
Condition: Thoracic

Bevacizumab solution in combination with Paclitaxel

Drugs: Avastin (bevacizumab solution for intravenous infusion) · Anti-VEGFR antibody, Avastin (intravenous infusion) , paclitaxel · Taxane
Condition: Breast

Ramucirumab in combination with paclitaxel

Drugs: Cyramza (ramucirumab) · Anti-VEGFR antibody, paclitaxel · Taxane
Condition: Gastrointestinal

Pertuzumab Injection

Drugs: PERJETA (pertuzumab) · Anti-HER2 antibody, trastuzumab · Anti-HER2 antibody, docetaxel · Taxane
Condition: Breast

Paclitaxel

Drug: Abraxane (paclitaxel) · Taxane
Condition: Gastrointestinal

FDA Approves Pertuzumab

Drugs: PERJETA (pertuzumab) · Anti-HER2 antibody, trastuzumab · Anti-HER2 antibody, docetaxel · Taxane
Condition: Breast

Cabazitaxel

Drug: Jevtana (cabazitaxel) · Taxane
Condition: Genitourinary

Bevacizumab Granted Accelerated Approval

Drugs: Avastin (bevacizumab) · Anti-VEGFR antibody, paclitaxel · Taxane
Condition: Breast

FDA Approves Docetaxel

Drug: Taxotere Injection Concentrate (docetaxel) · Taxane
Condition: Head & Neck

FDA approves Taxotere for use in combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck

Drugs: Taxotere Injection Concentrate (docetaxel) · Taxane, cisplatin · Platinum agent, fluorouracil · Fluoropyrimidine
Condition: Head & Neck