FDA Oncology Announcements

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8 Announcements

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 mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer

Trial: ENVISION
Drug: Zusduri (mitomycin intravesical solution) · Alkylating agent
Condition: Genitourinary

FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and pediatric patients with AML or MDS

Drugs: Grafapex (treosulfan) · Alkylating agent, fludarabine · Purine analog
Condition: Myeloid

FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer

Drug: ZEPZELCA (lurbinectedin) · Alkylating agent
Condition: Thoracic

FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer

Drug: ZEPZELCA (lurbinectedin) · Alkylating agent
Condition: Thoracic

FDA approves mitomycin for low-grade upper tract urothelial cancer

Trial: Olympus
Drug: JELMYTO (mitomycin) · Alkylating agent
Condition: Genitourinary

FDA approves mitomycin for low-grade upper tract urothelial cancer

Trial: Olympus
Drug: JELMYTO (mitomycin) · Alkylating agent
Condition: Genitourinary

Trabectedin

Drug: Yondelis (trabectedin) · Alkylating agent
Condition: Sarcoma