New immunotherapy drug Keytruda approved by FDA in combination with chemotherapy to fight early form of ‘tough-to-treat’ breast cancer
- Keytruda, developed by Merck & Co, has been approved by the FDA in combination with chemotherapy to treat triple negative breast cancer (TNBC)
- TNBC is a more dangerous form of breast cancer for which there were previously no treatments
- Around 10% to 15% of women who are diagnosed with breast cancer have TNBC and it has a higher risk of recurrence
- Keytruda has now been approved to combat 30 different types of cancer by the FDA
The U.S. Food and Drug Administration (FDA) had approved a new immunotherapy drug in combination with chemotherapy as a treatment for an early form of a tough-to-treat breast cancer.
Keytruda, developed by Kenilworth, New Jersey-based company Merck & Co Inc, received authorization on Tuesday.
The drug will be used to help treat triple-negative breast cancer (TNBC), an aggressive form of the disease with an increased risk of recurrence.
Trial data from more than 1,000 patients showed that Keytruda, when used with chemotherapy before surgery and then as a monotherapy after surgery, helped prolong the time that a patient remained free of cancer.
The combination therapy is the first time that a treatment regimen using an immunotherapy has been approved for patients with early-stage TNBC.
Keytruda (pictured) has been approved by the FDA to treat TNBC, a form of breast cancer that appears in 10% to 15% of patients
‘Triple-negative is a difficult-to-treat type of breast cancer that unfortunately is more common in the U.S. in younger women and in black women,’ said Dr Vicki Goodman, vice president, clinical research, Merck Research Laboratories, in a statement.
‘We are proud to offer a new treatment option for patients faced with this challenging cancer.
‘This neoadjuvant and adjuvant combination with Keytruda is the first immunotherapy regimen to be approved in high-risk early-stage TNBC, marking a meaningful milestone for the breast cancer community.’
Around 3.8 million Americans battle breast cancer every year , with ten to 15 percent diagnosed with TNBC.
It is most common in people below 40 years of age and who are African American.
Patients who are diagnosed with TNBC are less likely to survive, and less likely to be able to permanently beat the cancer.
The five-year survival rate of TNBC is 77 percent, compared to 90 percent for women diagnosed with other types of breast cancer.
Even if their cancer does go into remission, it is more likely to return than other types of breast cancer.
The aggressive form of cancer also is more likely to spread into other parts of the body.
It is also a ‘basal-like’ cancer, meaning the cancer cells are basal-shaped, which are often more serious cancers.
Medical professionals are unsure what causes TNBC.
There are not many currently available treatment options for TNBC because it does not include the specific hormones that typical breast cancer drugs target.
‘Even when TNBC is diagnosed early, 30 to 40 percent of patients will suffer cancer recurrence after standard neoadjuvant chemotherapy and surgery,’ said Dr Joyce O’Shaughnessy, chair of Breast Cancer Research at Baylor University Medical Center.
‘Therefore, there is a high unmet need for new treatment options. Today’s approval is very welcome news and has the potential to change the treatment paradigm by now including an immunotherapy as part of the regimen for patients with high-risk early-stage TNBC.’
The drug has also been approved to fight 30 types of cancer including lung cancer, Hodgkin lymphoma, stomach cancer and more.