Amgen said that sotorasib, an investigational KRASG12C inhibitor, has been given breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. The Chinese breakthrough therapy designation for sotorasib is for the treatment of patients having KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a significant boost to Pfizer’s lung cancer drug, Vizimpro (dacomitinib), recommending its approval as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). This recommendation specifically targets patients with epidermal growth factor receptor […]
Merck has achieved a significant milestone by obtaining approval from the European Commission (EC) for its cancer immunotherapy, Keytruda (pembrolizumab), to be used in combination with Eli Lilly’s chemotherapy drug pemetrexed (ALIMTA) and platinum chemotherapy. This approval specifically targets the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) in adults who do not […]