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CStone Announces New Drug Approval of GAVRETO(R) (pralsetinib) as First Selective RET Inhibitor in China, Providing a New Therapy for a Subset of Non-Small Cell Lung Cancer Patients
prnasia
March 24, 2021
CStone Pharmaceuticals, a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology therapies and precision medicines, today announces that the National Medical Products Administration (NMPA) of China has ...
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Roche’s Tecentriq improves disease-free survival in early lung cancer
pharmatimes
March 22, 2021
Roche’s PD-L1 inhibitor Tecentriq significantly improved disease-free survival (DFS) in patients with resectable, early stage non-small cell lung cancer (NSCLC), according to newly published Phase III data.
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Roche Receives FDA approval for VENTANA ALK CDx Assay with LORBRENA
americanpharmaceuticalreview
March 12, 2021
Roche announced US Food and Drug Administration (FDA) approval of the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with Pfizer's drug LORBRENA® ...
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MHRA authorises Lilly’s RET inhibitor Retsevmo
pharmatimes
March 11, 2021
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Eli Lilly’s Retsevmo a conditional marketing authorisation for the treatment of RET fusion-positive advanced lung cancer and thyroid cancer.
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Immutep Expands Part B of TACTI-002 Study
americanpharmaceuticalreview
March 10, 2021
Immutep has decided to expand Part B of its TACTI-002 Phase II trial, under the study’s Simon’s two- stage clinical trial design. Immutep has commenced recruitment of an additional 13 second line Non-Small Cell Lung Cancer (NSCLC) patients ...
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Novartis’ canakinumab fails to meet primary endpoint in lung cancer trial
pharmaceutical-technology
March 10, 2021
Novartis has reported that the Phase III CANOPY-2 study of canakinumab (ACZ885) in combination with the chemotherapy agent docetaxel failed to meet the primary endpoint of overall survival (OS) in patients with advanced or metastatic non-small cell ...
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FDA Approves Lorlatinib for Metastatic ALK-Positive NSCLC
americanpharmaceuticalreview
March 09, 2021
The U.S. Food and Drug Administration (FDA) has granted regular approval to lorlatinib (Lorbrena, Pfizer) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive ...
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Pfizer gets full US FDA nod for LORBRENA as first-line treatment for ALK-Positive metastatic NSCLC
expresspharma
March 04, 2021
Approval is based on CROWN trial, which showed a 72 per cent reduction in risk of progression or death for treatment with LORBRENA vs. XALKORI.
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FDA Approves Libtayo
americanpharmaceuticalreview
February 23, 2021
Regeneron Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high ...
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FDA Grants Sotorasib Priority Review Designation for Advanced, Metastatic NSCLC
americanpharmaceuticalreview
February 19, 2021
Amgen announced the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) ...