FDA approves Sarclisa + VRd for MM not eligible for transplant

FDA approves Tagrisso for stage 3 EGFR-mutated NSCLC

FDA approved Tagrisso (osimertinib) in the U.S. for treatment of adult patients with unresectable, stage 3 epidermal growth factor receptor-mutated non-small cell lung cancer whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy.

September 27, 2024

Vol.50 No.36

Drugs & Targets

Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

Bayer announced the submission of a supplemental new drug application to FDA for the oral androgen receptor inhibitor Nubeqa (darolutamide) in combination with androgen deprivation therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer.

September 27, 2024

Vol.50 No.36

Regulatory News

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

FDA approves Sarclisa + VRd for MM not eligible for transplant

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FDA approves Tagrisso for stage 3 EGFR-mutated NSCLC

Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

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

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FDA approves Sarclisa + VRd for MM not eligible for transplant

YOU MAY BE INTERESTED IN

FDA approves Tagrisso for stage 3 EGFR-mutated NSCLC

Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

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

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