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Merck receives first breast cancer approval in Europe for Keytruda

Merck’s anti-PD-1 therapy, Keytruda, is approved in the Europe Union for certain patients with triple-negative breast cancer plus chemotherapy

Merck & Co – known as MSD outside the US and Canada – has received its first European approval for Keytruda (pembrolizumab) in a breast cancer setting based on survival data from the phase 3 KEYNOTE-355 trial.

Keytruda can now be used as first-line treatment in combination with chemotherapy – investigator’s choice of paclitaxel, nab-paclitaxel or gemcitabine/carboplatin – to treat locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 and who have not received prior chemotherapy for metastatic disease.

Triple-negative breast cancer (TNBC) is an aggressive form of the disease with a high recurrence rate and more commonly diagnosed in in people who are younger than 40, who are black or who have a BRCA1 mutation.

In the KEYNOTE-355 trial, Keytruda plus chemo saw a 27% reduction in the risk of death and a 34% reduction in the risk of disease progression or death compared to chemotherapy alone.

“This approval is an important milestone for appropriate patients with metastatic TNBC who are in need of new treatment options,” said Dr Javier Cortés, head of the International Breast Cancer Center, a multidisciplinary team of breast cancer specialists.

“With this approval, patients in Europe with metastatic TNBC whose tumours express PD-L1 (CPS ≥10) have a new immunotherapy treatment option that can be used in combination with different chemotherapy agents,” he said.

Patients in all 27 European Union member states plus Iceland, Lichtenstein, Norway and Northern Ireland can now receive Keytruda in combination with chemotherapy.

Merck added that it will be “rapidly advancing” its broad portfolio in gynaecologic and breast cancers through “an extensive clinical development programme for KEYTRUDA and several other investigational and approved medicines”.

The company has the largest immuno-oncology clinical research programme with more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings currently underway.

Keytruda is approved in the same indication in the US as well as for patients with high-risk, early-stage TNBC in combination with chemotherapy as neoadjuvant treatment.

Earlier this month, Merck also secured approval for Keytruda in the US for the treatment of persistent, recurrent or metastatic cervical cancer which express PD-L1 in combination with chemotherapy, with or without bevacizumab based on data from the phase 3 KEYNOTE-826 trial.

Article by
Hugh Gosling

25th October 2021

From: Regulatory



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