FDA investigating possible increased risk of death with lymphoma drug Ukoniq

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

A group of melanoma experts, joined by three advocacy groups focused on melanoma, has engaged FDA in a public discussion of the challenges of developing new drugs in the refractory setting and the role crossover can play in such trials.

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

Drugs & Targets

FDA issues draft guidance on conducting multiregional clinical trials in oncology

FDA issued a draft guidance for industry that, when finalized, will provide sponsors with recommendations for conducting multiregional clinical trials in support of applications for drugs intended to treat cancer.

September 20, 2024

Vol.50 No.35

FDA investigating possible increased risk of death with lymphoma drug Ukoniq

YOU MAY BE INTERESTED IN

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

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

FDA issues draft guidance on conducting multiregional clinical trials in oncology

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FDA investigating possible increased risk of death with lymphoma drug Ukoniq

YOU MAY BE INTERESTED IN

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

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

FDA issues draft guidance on conducting multiregional clinical trials in oncology

Can you spare 10 minutes to complete a survey?

Login

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