Melanoma investigators invite FDA to publicly discuss approval endpoints and crossover design The agency accepts the invitation

Adjuvant treatment with cancer vaccine + Keytruda shows continued improvement in RFS and DMFS in resected high-risk advanced melanoma

Follow-up data from the phase IIb randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy, in combination with Keytruda in patients with resected high-risk melanoma (stage 3/4) following complete resection.

September 20, 2024

Vol.50 No.35

Clinical Roundup

Ten-year follow-up data shows Opdivo + Yervoy improves OS in advanced melanoma

Ten-year follow-up data from CheckMate-067, a randomized, double-blind, phase III clinical trial showed continued durable improvement in survival with first-line Opdivo (nivolumab) plus Yervoy (ipilimumab) therapy and Opdivo monotherapy, versus Yervoy alone, in patients with previously untreated advanced or metastatic melanoma.

September 20, 2024

Vol.50 No.35

Drugs & Targets

FDA approves Keytruda + pemetrexed + chemo in first-line mesothelioma indication

FDA has approved Keytruda in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma.

September 20, 2024

Vol.50 No.35

Drugs & Targets

FDA approves Rybrevant + pemetrexed + chemo in NSCLC with EGFR exon 19 deletions or L858R mutations

FDA approved Rybrevant (amivantamab-vmjw) with carboplatin and pemetrexed for 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 whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.

September 20, 2024

Vol.50 No.35

Drugs & Targets

FDA approves Kisqali + aromatase inhibitor for early high-risk breast cancer

FDA approved Kisqali (ribociclib) with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage 2 and 3 early breast cancer at high risk of recurrence.

September 20, 2024

Vol.50 No.35

Drugs & Targets

FDA grants Fast Track designation for ICT01 + Azacitidine + Venetoclax in treatment of first-line AML unfit for induction chemo

FDA granted Fast Track designation to ICT01 in combination with azacitidine and venetoclax for the treatment of acute myeloid leukemia patients 75 years or older, or who have comorbidities that preclude use of standard intensive induction chemotherapy.

September 20, 2024

Vol.50 No.35

Melanoma investigators invite FDA to publicly discuss approval endpoints and crossover design

The agency accepts the invitation

YOU MAY BE INTERESTED IN

Adjuvant treatment with cancer vaccine + Keytruda shows continued improvement in RFS and DMFS in resected high-risk advanced melanoma

Ten-year follow-up data shows Opdivo + Yervoy improves OS in advanced melanoma

FDA approves Keytruda + pemetrexed + chemo in first-line mesothelioma indication

FDA approves Rybrevant + pemetrexed + chemo in NSCLC with EGFR exon 19 deletions or L858R mutations

FDA approves Kisqali + aromatase inhibitor for early high-risk breast cancer

FDA grants Fast Track designation for ICT01 + Azacitidine + Venetoclax in treatment of first-line AML unfit for induction chemo

Renew today!

Subscriber content

Can you spare 10 minutes to complete a survey?

Login