Oncologists Now Have the Option to Treat Patients with KEYTRUDA®▼ (pembrolizumab) Every 6 Weeks with a New Dosing Schedule Across All Reimbursed Monotherapy Indications
Oncologists Now Have the Option to Treat Patients with KEYTRUDA®▼ (pembrolizumab) Every 6 Weeks with a New Dosing Schedule Across All Reimbursed Monotherapy Indications1
Pembrolizumab is now available in the UK in an extended 6-weekly dosing schedule, which can help ease the strain on oncologists by providing flexibility in how often they treat cancer patients across all reimbursed monotherapy indications
Hoddesdon, 4th April, 2019 - Today, MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE: MRK)) are proud to announce that the European Commission (EC) has approved KEYTRUDA®▼ (pembrolizumab) for six-week dosing schedule across all current monotherapy indications. Oncologists now have the flexibility to treat cancer patients across the reimbursed monotherapy indications at 6-weekly intervals with immediate effect.
Professor James Larkin, Consultant Medical Oncologist at The Royal Marsden said, “This is excellent news for patients and is a significant step forward as it gives much greater flexibility, because it is only necessary to attend hospital every 6 weeks rather than every three weeks for treatment. Hundreds of people across the UK are being treated with pembrolizumab for melanoma and will need less frequent hospital visits, which is especially important for those patients that travel long distances for their treatment.”
Louise Houson, Managing Director, MSD UK & Ireland, said, “Working with the NHS is paramount to MSD, and as such we are well aware of the pressures oncologists are facing when treating a growing population of patients. As pembrolizumab now gives oncologists the option in how regularly they treat patients across a number of different tumour types, we are making progress in freeing up much-needed oncologist capacity whilst providing effective and sustainable treatments for a rising patient population. MSD remains committed to improving the lives of people living with cancer, which includes the ability to offer greater flexibility in administering pembrolizumab. The extended dosing schedule further demonstrates MSD’s commitment to helping to improve the lives of patients with many types of cancer.”
The UK’s oncologist workforce is under serious strain, being 18% understaffed of clinical oncologists. Without investment this gap is expected to expand to 22% by 2023. To close this gap between supply and demand for oncologists, the number of clinical oncology trainees would need to at least double, at which point the gap wouldn’t even be closed until 2029.2 This is all whilst the number of new cancer cases in the UK rises – in 2016, 303,135 new cases were recorded in England alone. The extended dosing schedule could help relieve the strain on oncologists by providing much-needed flexibility in the frequency of patient treatment appointments, freeing up oncologist capacity. This new indication allows certain patients with advanced melanoma, certain patients with untreated and previously treated non-small cell lung cancer, classical Hodgkin lymphoma and bladder cancer, the option to be treated with pembrolizumab monotherapy every 6 weeks in the UK, and patients with stage III melanoma who have had resection in England.1
Imogen Cheese, founder of Melanoma Patient Conference and melanoma patient, said “Patients lose so much when diagnosed with cancer, so the news that the pembrolizumab dosing might give patients time back is great progress. Dosing at 6 weeks rather than every 3 weeks means patients can visit the hospital less & try to continue with their lives whilst continuing their treatment regimen.”
Notes to editors:
Pembrolizumab is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumour cells. Pembrolizumab blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, pembrolizumab releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumour immune response.1
For detailed information regarding pembrolizumab, please refer to the Summary of Product Characteristics, available online at https://www.medicines.org.uk/emc/product/6947/smpc
Our Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At MSD Oncology, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer.
For more than a century, MSD, a leading global biopharmaceutical company, has been bringing forward medicines and vaccines for the world’s most challenging diseases. MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programmes and partnerships. Today, MSD continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world. For more information, visit www.msd-UK.com and connect with us on Twitter @MSDintheUK.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbour provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2016 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
 Medicines.org.uk. (2019). KEYTRUDA 50 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC) - (eMC). [online] Available at: https://www.medicines.org.uk/emc/product/6947/smpc [Accessed March 2019].
 RCR's Clinical Oncology UK Workforce Census Report 2018. (2019). [online] p.5. Available at: https://www.rcr.ac.uk/system/files/publication/field_publication_files/bfco192-co-workforce-census-2018.pdf [Accessed March 2019].
 Ellis, K. (2019). Cancer registration statistics, England - Office for National Statistics. [online] Ons.gov.uk. Available at: https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/bulletins/cancerregistrationstatisticsengland/final2016 [Accessed March 2019].