FDA grants Orphan Drug designation to elraglusib for soft tissue sarcomas

Factors outside CAR T-cell therapy are associated with increased risk of secondary cancers after the treatment, meta-analysis shows
Subgroup analysis suggests risk of secondary cancers after CAR T-cell therapy is similar to risk after other therapies

A meta-analysis of 25 studies—totaling over 5,000 participants—focused on a question that has been troubling patients, physicians, and regulators: Does treatment with CAR T-cell therapy contribute to the development of secondary cancers?

September 13, 2024

Vol.50 No.34

By McKenzie Prillaman

Drugs & Targets

FDA approves Tecentriq Hybreza for subcutaneous PD-(L)1 cancer immunotherapy

FDA approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous injection.

September 13, 2024

Vol.50 No.34

Drugs & Targets

FDA seeks consumer representatives for the Oncologic Drugs Advisory Committee

FDA is seeking consumer representatives to serve on the Oncologic Drugs Advisory Committee.

September 13, 2024

Vol.50 No.34

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

FDA grants Orphan Drug designation to elraglusib for soft tissue sarcomas

YOU MAY BE INTERESTED IN

Factors outside CAR T-cell therapy are associated with increased risk of secondary cancers after the treatment, meta-analysis shows
Subgroup analysis suggests risk of secondary cancers after CAR T-cell therapy is similar to risk after other therapies

FDA approves Tecentriq Hybreza for subcutaneous PD-(L)1 cancer immunotherapy

FDA seeks consumer representatives for the Oncologic Drugs Advisory Committee

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

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FDA grants Orphan Drug designation to elraglusib for soft tissue sarcomas

YOU MAY BE INTERESTED IN

Factors outside CAR T-cell therapy are associated with increased risk of secondary cancers after the treatment, meta-analysis showsSubgroup analysis suggests risk of secondary cancers after CAR T-cell therapy is similar to risk after other therapies

FDA approves Tecentriq Hybreza for subcutaneous PD-(L)1 cancer immunotherapy

FDA seeks consumer representatives for the Oncologic Drugs Advisory Committee

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

Can you spare 10 minutes to complete a survey?

Login

Factors outside CAR T-cell therapy are associated with increased risk of secondary cancers after the treatment, meta-analysis shows
Subgroup analysis suggests risk of secondary cancers after CAR T-cell therapy is similar to risk after other therapies