ODAC reviews two longest-running accelerated approvals as FDA weighs using its new authority

FDA approves Rybrevant + Lazcluze for NSCLC

FDA approved Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

September 06, 2024

Vol.50 No.33

Drugs & Targets

FDA approves neoadjuvant/adjuvant Imfinzi for resectable NSCLC

FDA approved durvalumab (Imfinzi) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.

September 06, 2024

Vol.50 No.33

Drugs & Targets

FDA accepts Bristol Myers Squibb’s sBLA for Opdivo + Yervoy in unresectable HCC

FDA accepted Bristol Myers Squibb’s supplemental Biologics License Application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment for adult patients with unresectable hepatocellular carcinoma.

September 06, 2024

Vol.50 No.33

Drugs & Targets

FDA grants Imfinzi priority review and Breakthrough Therapy designation for limited-stage SCLC

FDA granted priority review for Imfinzi (durvalumab), AstraZeneca’s supplemental Biologics License Application, based on the results from the positive ADRIATIC phase III trial in patients with limited-stage small cell lung cancer whose disease has not progressed following platinum-based concurrent chemoradiotherapy.

September 06, 2024

Vol.50 No.33

Drugs & Targets

FDA approves Voranigo for grade 2 IDH-mutant glioma

FDA has approved Voranigo (vorasidenib), an isocitrate dehydrogenase-1 and isocitrate dehydrogenase-2 inhibitor, for the treatment of adult and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.

August 09, 2024

Vol.50 No.32

Drugs & Targets

FDA approves Lymphir immunotherapy for r/r CTCL

FDA has approved Lymphir (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of r/r cutaneous T-cell lymphoma after at least one prior systemic therapy.

August 09, 2024

Vol.50 No.32

ODAC reviews two longest-running accelerated approvals as FDA weighs using its new authority

YOU MAY BE INTERESTED IN

FDA approves Rybrevant + Lazcluze for NSCLC

FDA approves neoadjuvant/adjuvant Imfinzi for resectable NSCLC

FDA accepts Bristol Myers Squibb’s sBLA for Opdivo + Yervoy in unresectable HCC

FDA grants Imfinzi priority review and Breakthrough Therapy designation for limited-stage SCLC

FDA approves Voranigo for grade 2 IDH-mutant glioma

FDA approves Lymphir immunotherapy for r/r CTCL

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