AstraZeneca has reported positive results from the COAST phase 2 trial of its oleclumab or monalizumab in combination with Imfinzi (durvalumab) in patients with non-small cell lung cancer (NSCLC). The pharma giant said that the mid-stage clinical trial showed the experimental combinations to have improved progression-free survival (PFS) as well as objective response rate (ORR). […]
Cadila Healthcare (also known as Zydus Cadila) said that it has secured tentative approval from the US Food and Drug Administration (FDA) for marketing Pemetrexed for Injection in 100mg/vial, 500mg/vial, and 1000mg/vial, single-dose vials. Pemetrexed for Injection is the generic for Eli Lilly and Company (Lilly) owned Pemetrexed, which is sold under Alimta and other […]
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 […]
AstraZeneca has signed a deal potentially worth up to $6 billion with Daiichi Sankyo for the global development and commercialization for the latter’s DS-1062, a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC), which is being developed for the treatment of multiple tumor types. Daiichi Sankyo is developing the antibody drug conjugate for multiple tumors […]
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 […]
Genetron Health has been granted approval by China’s National Medical Products Administration (NMPA) for GENETRON S5, its semiconductor-based next-generation sequencing system (NGS system). With the approval, the Chinese precision oncology company can launch the new desktop medium-throughput NGS system for clinical applications. The NGS system has been developed by Genetron Health for the detection of […]
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 […]
Biodesix, a lung cancer diagnostic solutions company, has acquired UK-based Oncimmune’s laboratory and incidental pulmonary nodule (IPN) malignancy test in the US, to expand its blood-based lung cancer diagnostic portfolio. Oncimmune’s US commercial and lab operations, including a Clinical Laboratory Improvement Amendments (CLIA) lab in DeSoto, Kansas, has now been transferred to Biodesix. The Kansas […]