t epotinib c-Met kinase inhibitor Non-small cell lung cancer tepotinib c-Met kinase inhibitor Hepatocellular cancer avelumab anti-PD-L1 mAb Merk el cell cancer 1L 1 sprifermin fibroblast growth factor 18 O steoarthritis atacicept anti-Blys /anti-APRIL fusion protein Systemic lupus erythematosus atacicept anti-Blys /anti-APRIL fusion protein IgA nephropathy abituzumab anti-CD 51 mAb Systemic sclerosis with interstitial lung dis. evobrutinib BTK inhibitor R heumatoid arthritis evobrutinib BTK inhibitor Systemic lupus erythematosus evobrutinib BTK inhibitor Multiple sclerosis 1 Merck pipeline M2698 p70S6K & Akt inhibitor Solid tumors M3814 DNA-PK inhibitor Solid tumors M9831 (VX-984) DNA-PK inhibitor Solid tumors M6620 (VX-970) ATR inhibitor Solid tumors M4344 (VX-803) ATR inhibitor Solid tumors M7583 BTK inhibitor Hem atological malignancies avelumab anti-PD-L1 mAb Solid tumors avelumab anti-PD-L1 mAb Hem atological malignancies M9241 (NHS-IL12) 8 Cancer immunotherapy Solid tumors M7824 anti-PD-L1/ TGFbeta trap Solid tumors M1095 (ALX-0761) 10 anti-IL-17 A/F nanobody Psoriasis Registration Phase III Phase II Phase I cladribine 4 tablets lymphocyte targeting agent Relapsing-remitting multiple sclerosis avelumab 6 anti-PD-L1 mAb Merk el cell cancer (EU) avelumab-anti-PD-L1 mAb Non-small cell lung cancer 1L 1 avelumab-anti-PD-L1 mAb Non-small ce ll lung cancer 2L 2 avelumab-anti-PD-L1 mAb Gastric cancer 1L-M 1M avelumab-anti-PD-L1 mAb Gastric cancer 3L 3 avelumab-anti-PD-L1 mAb O varian cancer platinum resistant/refractory avelumab-anti-PD-L1 mAb O varian cancer 1L 1 avelumab-anti-PD-L1 mAb Urothelial cancer 1L-M 1M avelumab-anti-PD-L1 mAb Renal cell cancer 1L 1 avelumab-anti-PD-L1 mAb Locally advanced head and neck cancer MSB 11022 9 proposed biosimilar of adalimumab Chronic plaque psoriasis 1 First Line treatment; 1M First Line maintenance treatment; 2 Second Line treatment; 3 Third Line treatment; 4 As announced on July 18, 2016, the EMA has accepted for review the Marketing Authorization Application (MAA) of Cladribine Ta ble ts for the treatment of relapsing-remitting multiple sclerosis. 5 As announced on March 23, 2017, the US FDA has granted accelerated approved of avelumab for the treatment of adults and pedia tri c patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication was approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab has not yet been approved for metastatic MCC outside of the US. 6 As announced on October 31, 2016, the EMA has validated for review Merck’s MAA for avelumab, for the proposed indication of m eta static Merkel cell cancer. 7 As announced on May 9, 2017 the US FDA granted accelerated approval of avelumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy therapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication was approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab has not yet been approved f or metastatic UC outside of the US. 8 Sponsored by the National Cancer Institute (USA). 9 On April 24, 2017 the divestment of Merck’s Biosimilars business to Fresenius was announced. Closing is expected in H2, 2017, s ubject to regulatory approvals and other conditions. 10 As announced on March 30, 2017 in an agreement with Avillion, anti-IL-17 A/F nanobody will be developed by Avillion for plaque psoriasis and commercialized by Merck. May 18, 2017 Recently Registered avelumab 5-anti-PD-L1 mAb Merk el cell cancer (US) avelumab 7-anti-PD-L1 mAb Urothelial cancer (US) Neurology Oncology Immunology Immuno-Oncology B iosimilars P ipeline products are under clinical investigation and have not been proven to be s afe and effective. T here is no guarantee any product will be approved in the s ought-after indication.
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