Y-mAbs announces U.S. FDA acceptance of biologics license application for Danyelza (naxitamab) for the treatment of neuroblastoma for priority review

2 June 2020 - Y-mAbs Therapeutics today announced that the biologics license application for Danyelza (naxitamab) for the treatment of patients ...

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CDK 4/6 inhibitor market to heat up on insurance benefits

2 June 2020 - Despite such high unmet medical needs, the drug has long been out of reach for patients ...

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Ribociclib succinate in breast cancer: added benefit for certain post-menopausal women

2 June 2020 - Re-valuations after the expiry of the time limit new data cuts confirm advantages and disadvantages ...

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European Commission approves Sarclisa (isatuximab) for adults with relapsed and refractory multiple myeloma

2 June 2020 - EC approval based on data from first randomised Phase 3 trial (ICARIA-MM) to report results evaluating an ...

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AVEO Oncology announces FDA acceptance for filing of a new drug application for tivozanib as a treatment of relapsed or refractory renal cell carcinoma

1 June 2020 - Tivozanib assigned PDUFA target action date of 31 March 2021; FDA indicates that it does not currently ...

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Lynparza recommended for approval in EU by CHMP for BRCA mutated metastatic pancreatic cancer

1 June 2020 - Only PARP inhibitor to demonstrate patient benefit in a Phase III trial in this setting. ...

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New combination therapy now reimbursed for Australians living with incurable blood cancer

 1 June 2020 - New combination therapy now reimbursed for Australians living with incurable blood cancer. ...

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CHMP recommends EU approval of Roche’s Rozlytrek for people with NTRK fusion-positive solid tumours and for people with ROS1-positive, advanced non-small cell lung cancer

29 May 2020 - Rozlytrek has shown durable responses across multiple tumour types, including cancer that has spread to the brain, ...

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Novartis Piqray receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation

29 May 2020 - Piqray (alpelisib) in combination with fulvestrant will become first and only targeted treatment for advanced breast ...

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FDA approves Genentech’s Tecentriq in combination with Avastin for people with the most common form of liver cancer

29 May 2020 - Application approved under FDA’s Project Orbis initiative and Real-Time Oncology Review pilot program. ...

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Lilly's Cyramza (ramucirumab) receives FDA approval as first-line treatment for metastatic EGFR mutated non-small cell lung cancer

29 May 2020 - Cyramza, in combination with erlotinib, now approved for the treatment of people with untreated metastatic non-small cell ...

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Cardiff Oncology announces fast track designation granted by the FDA to onvansertib for second-line treatment of KRAS mutated colorectal cancer

28 May 2020 - Fast Track designation for onvansertib in KRAS mutated metastatic colorectal cancer underscores the urgent need for new ...

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NICE issues final guidance on NHS use of Bayer's Vitrakvi

27 May 2020 - The NICE has published final guidance recommending NHS use of Bayer's Vitrakvi (larotrectinib) for a variety ...

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NICE recommends treatment for type of small-cell lung cancer

27 May 2020 - A new treatment option for patients with extensive-stage small-cell lung cancer has been approved by NICE. ...

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U.S. FDA approves Opdivo (nivolumab) and Yervoy (ipilimumab) combined with limited chemotherapy as first-line treatment of metastatic or recurrent non-small cell lung cancer

26 May 2020 - Approval marks sixth indication for Opdivo and Yervoy-based combinations across five types of cancer. ...

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