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AstraZeneca gets FDA approval for Tagrisso for type of NSCLC

AstraZeneca gets FDA approval for Tagrisso for type of NSCLC

AstraZeneca has secured extended approval from the US Food and Drug Administration for using Tagrisso (osimertinib) as an adjuvant treatment of non-small cell lung cancer (NSCLC) in patients whose tumors have a certain type of genetic mutation. According to the FDA, nearly 20% of patients with non-small cell lung cancer will have epidermal growth factor […]

BMS’ Opdivo plus Yervoy combo gets EC approval for metastatic NSCLC

Bristol Myers Squibb (BMS) has secured approval from the European Commission (EC) for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC). The approval is for the Opdivo/Yervoy combination to be used with two cycles of platinum-based chemotherapy in adult patients, whose tumors have no sensitizing epidermal growth […]

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Blueprint Medicines strikes $1.7bn worth deal with Roche for pralsetinib

Swiss pharma giant Roche and US precision therapy company Blueprint Medicines have entered into a worldwide licensing and collaboration deal potentially worth up to $1.703 billion for the latter’s cancer drug candidate pralsetinib. Through the deal, Roche gains exclusive rights for the co-development and marketing of the investigational drug for RET-altered cancers across the world […]

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Selpercatinib FDA approval : Lilly’s therapy approved for treatment of lung and thyroid cancers with RET alteration

Selpercatinib FDA approval : The US Food and Drug Administration (FDA) has approved Eli Lilly and Company’s Retevmo (selpercatinib) capsules for the treatment of three types of tumors – non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancers. The approvals are for the drug to be used in patients whose tumors […]

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Lilly bags Retevmo FDA approval for RET-driven lung and thyroid cancers

Retevmo FDA approval : Eli Lilly and Company (Lilly) has secured approval from the US Food and Drug Administration (FDA) for Retevmo (selpercatinib, 40mg and 80mg capsules) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). Retevmo has also been approved by the FDA for the treatment […]

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Lilly launches LIBRETTO-431 clinical trial for selpercatinib in NSCLC

Eli Lilly and Company (Lilly) has initiated the phase 3 LIBRETTO-431 clinical trial to evaluate selpercatinib (LOXO-292) in RET fusion-positive non-small cell lung cancer (NSCLC) in patients who are treatment-naïve. The US pharma company is aiming to enroll 400 patients in the late-stage clinical trial. The patients will be grouped randomly to be subjected to […]

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ALTA-1L trial results : Takeda’s ALUNBRIG continues to show superiority over crizotinib

ALTA-1L trial results : Takeda Pharmaceutical says that ALUNBRIG (brigatinib), its tyrosine kinase inhibitor (TKI), is continuing to show superiority over crizotinib in the phase 3 ALTA-1L trial. The Japanese pharma company released updated data from the late-stage trial involving adult patients having advanced anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) who did […]

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Genentech bags Rozlytrek FDA approval for two rare types of cancer

Rozlytrek FDA approval : Roche’s subsidiary Genentech has bagged approvals for Rozlytrek (entrectinib) from the US Food and Drug Administration (FDA) for a type of non-small cell lung cancer (NSCLC) and for certain forms of solid tumors. The first Rozlytrek FDA approval is for the treatment of ROS1-positive, metastatic NSCLC in adult patients. Additionally, Rozlytrek […]

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Tagrisso FLAURA trial results : AstraZeneca NSCLC drug significantly improves OS

Tagrisso FLAURA trial results : Pharma giant AstraZeneca said that the phase 3 FLAURA trial evaluating Tagrisso (osimertinib) in previously untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) has yielded positive overall survival (OS) results. The randomized, double-blinded, multicenter late-stage trial featured NSCLC patients whose tumors have epidermal growth factor receptor (EGFR) […]

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Pfizer lung cancer drug Vizimpro bags CHMP’s positive opinion

The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Pfizer lung cancer drug Vizimpro (dacomitinib) 45 mg in Europe as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The positive opinion adopted by the European Medicines Agency (EMA) committee is […]

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