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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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Keytruda fluffs its lines in prostate, liver cancer trials

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The CRPC trial – KEYNOTE-921 – looked at the combination of Keytruda (pembrolizumab) with docetaxel in more than 1,000 patients who had not been treated with chemotherapy before, but who had seen disease progression despite earlier treatment with an anti-hormonal therapy.

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Targeting tumours with novel radiopharmaceuticals

European Pharmaceutical Review

The development of novel radiotherapeutics ushered in a new era in targeted treatment 1 for cancer, with two separate radiotherapeutic approvals in Europe and the US, in 2018 and 2022. How do you perceive radiopharmaceuticals complementing existing cancer treatments, such as chemotherapy and immunotherapy?

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Tuoyi to transform treatment of recurrent/metastatic nasopharyngeal carcinoma

Pharmaceutical Technology

Patients in the US and EU with recurrent or metastatic nasopharyngeal carcinoma (NPC), a subtype of head and neck squamous cell carcinoma (HNSCC), are mostly treated with a combination of chemotherapy agents in the frontline setting, such as cisplatin + gemcitabine. months for the chemotherapy arm (hazard ratio [HR]: 0.52).

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Roche nabs breakthrough tag for TIGIT cancer immunotherapy

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Roche’s drug is already FDA-approved as a monotherapy and in combination with Avastin (bevacizumab) and chemotherapy for previously-untreated NSCLC with high PD-L1 expression.

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FDA approves under-pressure GSK’s Jemperli for endometrial cancer

pharmaphorum

While some argued that GSK overpaid for Tesaro in 2018, at least the deal is bringing badly needed new drugs to market for the under-pressure UK pharma and its highly-paid research chief Hal Barron.

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Fennec’s hearing loss drug for cancer patients wins breakthrough FDA nod

Pharmaceutical Technology

The current standard of care for many cancers is cisplatin chemotherapy or platinum therapy. In 2018, the FDA had granted Pedmark a breakthrough orphan drug designation. These open-label, randomized clinical trials were done in patients under 18 years of age. Pedmark clinical trials.