FDA Oncology Announcements

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25 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 neoadjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma

Trial: MK-3475-689
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Head & Neck

FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma

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

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 grants accelerated approval to repotrectinib for adult and pediatric patients with NTRK gene fusion-positive solid tumors

Trial: TRIDENT-1
Drug: AUGTYRO (repotrectinib) · ROS1 inhibitor
Condition: Other solid neoplasm

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors

Trials: DPT02, DESTINY-Lung01, DESTINY-CRC02
Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Other solid neoplasm

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 expands pediatric indication for entrectinib and approves new pellet formulation

Trial: STARTRK-NG
Drug: Rozlytrek (entrectinib) · TRK inhibitor
Condition: Other solid neoplasm

FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

Drug: Retevmo (selpercatinib) · RET inhibitor
Condition: Other solid neoplasm

FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors

Trial: SIOPEL6
Drug: Pedmark (sodium thiosulfate)
Condition: Other solid neoplasm

FDA grants accelerated approval to dabrafenib in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutation

Drugs: Tafinlar (dabrafenib) · BRAF inhibitor, Mekinist (trametinib) · MEK inhibitor
Condition: Other solid neoplasm

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 new dosing regimen for cetuximab

Drug: Erbitux (cetuximab) · Anti-EGFR antibody
Conditions: GastrointestinalHead & Neck

FDA Approves Companion Diagnostic to identify NTRK fusions in solid tumors for Vitrakvi

Trials: SCOUT, NAVIGATE
Condition: Other solid neoplasm

FDA Approves Companion Diagnostic to identify NTRK fusions in solid tumors for Vitrakvi

Trials: SCOUT, NAVIGATE
Condition: Other solid neoplasm

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 pembrolizumab for first-line treatment of head and neck squamous cell carcinoma

Trial: MK-3475-048
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Head & Neck

FDA approves larotrectinib for solid tumors with NTRK gene fusions

Drug: VITRAKVI (larotrectinib) · TRK inhibitor
Condition: Other solid neoplasm

Nivolumab for SCCHN

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Condition: Head & Neck

pembrolizumab (KEYTRUDA)

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Head & Neck

Cetuximab (Erbitux)

Drug: Erbitux (cetuximab) · Anti-EGFR antibody
Condition: Head & Neck

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

Erbitux (ceuximab) Approved for Use in Combination with Radiation Therapy

Drug: Erbitux (cetuximab) · Anti-EGFR antibody
Condition: Head & Neck