FDA grants orphan drug designation to UV1 cancer vaccine in metastatic melanoma

Jeffrey S. Weber, pioneering immunologist and melanoma expert at NYU, dies at 72

We lost Jeff Weber, an amazing medical oncologist, an impactful clinical scientist, a leading immunotherapist, and one of the prominent global experts in melanoma.

September 06, 2024

By Bernard A. Fox, James J. Mulé and Samir N. Khleif

Drugs & Targets

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

Clinical Roundup

Distinct pattern in protein production can predict severe side effects from skin cancer treatment

An activity pattern in certain genes responsible for building proteins known as spleen tyrosine kinases can predict which melanoma patients are likely to have severe side effects from immunotherapy designed to treat the most deadly skin cancer, a study shows.

August 09, 2024

Vol.50 No.32

FDA grants orphan drug designation to UV1 cancer vaccine in metastatic melanoma

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Jeffrey S. Weber, pioneering immunologist and melanoma expert at NYU, dies at 72

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

Distinct pattern in protein production can predict severe side effects from skin cancer treatment

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