Puma’s neratinib receives EU approval for early stage HR+, HER2+ BC extended adjuvant treatment

Puma Biotechnology receives European marketing authorization for neratinib (Nerlynx) for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-overexpressed/amplified breast cancer (BC) and who are less than 1 year from the completion of prior adjuvant trastuzumab-based therapy.

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EC approves Merck’s pembrolizumab + pemetrexed-platinum chemotherapy for 1L metastatic non-squamous NSCLC with no EGFR or ALK mutations

Merck’s pembrolizumab (Keytruda) receives supplemental approval from the European Commission (EC) for use in combination with Lilly’s pemetrexed (Alimta) and platinum chemotherapy for the first-line (1L) treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adults whose tumors have no epidermal growth factor receptor (EGFR)– or anaplastic lymphoma kinase (ALK)-positive mutations.

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Chi-Med’s fruquintinib receives Chinese approval for previously treated mCRC

Hutchison China MediTech (Chi-Med) announces that fruquintinib has received approval from the National Medical Products Administration of China for treatment of metastatic colorectal cancer (mCRC) patients after failure of at least 2 prior systemic antineoplastic therapies (including fluoropyrimidine, oxaliplatin, and irinotecan, with or without prior use of anti-vascular endothelial growth factor or anti-epidermal growth factor […]

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SillaJen’s/Lee’s Pharmaceutical’s phase III advanced HCC trial of Pexa-Vec enrolls first patient

SillaJen and Lee’s Pharmaceutical enroll the first patient in China in the phase III PHOCUS clinical trial comparing overall survival with their oncolytic immunotherapy Pexa-Vec (formerly JX-594) followed by sorafenib vs sorafenib alone in patients with advanced hepatocellular carcinoma (HCC) who have not received prior systemic treatment. Click here to go to the full article

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