FDA, industry actions end sales of PFAS in U.S. food packaging

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

FDA, industry actions end sales of PFAS in U.S. food packaging

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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