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CHMP advises approval for Bristol Myers Squibb’s Opdivo plus Yervoy with chemo for metastatic NSCLC expresspharma
September 21, 2020
The European Commission will now review the CHMP recommendation.
Blueprint Announces FDA Approval of GAVRETO for Metastatic Non-Small Cell Lung Cancer americanpharmaceuticalreview
September 17, 2020
Blueprint Medicines announced the U.S. Food and Drug Administration (FDA) has approved GAVRETO™ (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer ...
FDA Approves GAVRETO for Metastatic Rearranged During Transfection Fusion-Positive NSCLC americanpharmaceuticalreview
September 16, 2020
The U.S. Food and Drug Administration (FDA) approved GAVRETO (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
NICE backing for AZ' Tagrisso pharmatimes
September 15, 2020
AstraZeneca's Tagrisso (osimertinib) has been recommended for use within NHS England, in line with its licensed indication, for adults with untreated locally-advanced or metastatic epidermal growth factor receptor (EGFR) ...
Genentech's Gavreto cleared for RET non-small cell lung cancer pharmatimes
September 08, 2020
US regulators have approved Genentech's Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC).
Roche’s Genentech gets US FDA approval for Gavreto (pralsetinib) expresspharma
September 07, 2020
The drug is used to treat metastatic RET fusion-positive non-small cell lung cancer.
FDA Accepts NDA Filing for Tepotinib for Metastatic NSCLC with METex14 Skipping Alterations americanpharmaceuticalreview
August 26, 2020
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, has announced the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the new drug application (NDA) for ...
Imfinzi Granted FDA Priority Review for Less-Frequent, Fixed-Dose Use americanpharmaceuticalreview
August 21, 2020
AstraZeneca's Imfinzi (durvalumab) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for a new four-week, fixed-dose regimen for treatment in the approved indications ...
Priority review for Imfinzi's less-frequent dosing regimen pharmatimes
August 19, 2020
AstraZeneca's Imfinzi (durvalumab) has been granted a priority review in the US for a new four-week, fixed-dose regimen for treatment of non-small cell lung cancer (NSCLC) and bladder cancer.
Thermo Fisher Scientific Signs CDx Agreement with Hengrui Therapeutics contractpharma
August 18, 2020
Will leverage the Oncomine Precision Assay to identify non-small cell lung cancer patients who may benefit from pyrotinib.

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