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New era of genomic medicine begins as UK approves Lilly’s Retsevmo

pharmaphorum

The UK Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional approval for Retsevmo (selpercatinib) as monotherapy for adults with advance RET fusion-positive non-small cell lung cancer requiring systemic therapy after previous immunotherapy and/or chemotherapy treatment.

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Failed trial nixes another FDA approval, this time for BMS’ Istodax

pharmaphorum

The HDAC inhibitor was given an accelerated approval by the FDA as a second-line PTCL therapy on the strength of overall response data, but a phase 3 study comparing Istodax to first-line chemotherapy showed no improvement on progression-free survival (PFS).

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BMS sets up Roche, Pfizer rivalry with Turning Point takeover

pharmaphorum

Rozlytrek was approved by the FDA in 2019 but has just started to gather sales momentum, making around $17 million in the first quarter of this year, an increase of 78% on the first three months of 2021. billion product, mainly from first-line use, if it can claim FDA approval for a broad label covering any ROS1-positive cancer.

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Targeting tumours with novel radiopharmaceuticals

European Pharmaceutical Review

How do you perceive radiopharmaceuticals complementing existing cancer treatments, such as chemotherapy and immunotherapy? There is great hope of this class of drug specifically to work in conjunction with immunotherapeutics, given the lack of toxicity of radiopharmaceuticals in general compared to most chemotherapies.

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Novel oral chemotherapeutic holds potential for stomach cancer patients

European Pharmaceutical Review

The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drug development. Benefits of daily oral chemotherapy over IV.

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AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Pharmaceutical Technology

The treatment is indicated for patients who have previously received chemotherapy in the metastatic setting or recurred during or within six months of receiving adjuvant chemotherapy. The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial.

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EMA starts review of Enhertu for HER2+ gastric cancer

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Around one in five gastric cancers are HER2-positive, opening up a new market for AZ and Daiichi Sankyo, which have been collaborating on Enhertu since signing a multi-billion partnership for the drug in 2019. billion licensing deal. The post EMA starts review of Enhertu for HER2+ gastric cancer appeared first on.