pharmaphorum

MARCH 2, 2021

Merck & Co has voluntarily withdrawn its Keytruda immunotherapy from a lung cancer niche in the US, amid a crackdown by the FDA on drugs approved without the required post-marketing data. Merck & Co said it had withdrawn the indication after consultation with the FDA and is working to complete the process over the coming weeks.

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European Pharmaceutical Review

AUGUST 12, 2024

Progress in immunotherapy drug development In June, the US Food and Drug Administration (FDA) authorised an immunotherapy combination to treat endometrial cancer. The bispecific antibody has shown potential to generate “significant and sustained reductions in B-cell populations”. The deal is anticipated to be finalised in Q3 of 2024.

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Pharmaceutical Technology

APRIL 4, 2023

Merck has secured approval from the US Food and Drug Administration (FDA) for KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) for first-line treatment of some adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). 12% experienced a complete response and 55% a partial response.

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European Pharmaceutical Review

JUNE 18, 2024

The US Food and Drug Administration (FDA) has approved the first anti-PD-1 therapy in combination with chemotherapy for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status. In the placebo plus carboplatin and paclitaxel arm, PFS was 6.5

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Pharmaceutical Technology

AUGUST 5, 2022

Earlier, these patients received neoadjuvant or adjuvant chemotherapy. The US Food and Drug Administration (FDA) approved Lynparza in March for this indication. The treatment is indicated for people with germline BRCA1/2 mutations (gBRCAm) and have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer.

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pharmaphorum

OCTOBER 14, 2021

The FDA has approved Merck’s Keytruda as a first-line therapy for advanced cervical cancer. Keytruda (pembrolizumab) can be used in combination with chemotherapy, with or without bevacizumab, to treat patients with persistent, recurrent or metastatic cervical cancer where the tumour expresses a certain level of PD-L1.

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