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Merck & Co.
Currently, Merck is reviewing this CRL and will discuss next steps with the FDA.
ODAC provides independent expert opinions and suggestions to the FDA for the drugs that are already on the market and investigational drugs used to treat cancer.
In July 2020, the FDA accepted two sBLAs for the treatment of TNBC by Keytruda.
Another sBLA, the above-mentioned sBLA that received the CRL, has undergone a standard review: Keytruda is used for high-risk early TNBC patients.
It should be pointed out that this CRL does not affect any currently approved Keytruda indications, including the above approved: Keytruda combined with chemotherapy for the treatment of locally recurrent unresectable or metastatic TNBC with tumors expressing PD-L1 (CPS≥10) patient.
KEYNOTE-522 is a randomized, double-blind trial conducted in high-risk early TNBC patients.
The data shows that during the neoadjuvant treatment period, regardless of the PD-L1 expression status, compared with chemotherapy (n=201), Keytruda + chemotherapy (n=401) showed statistically significant pathological complete remission (pCR) Increase (pCR: 64.
It is worth mentioning that, based on the research data, Keytruda is the first anti-PD-1 therapy to show statistically significant improvement in pCR as a neoadjuvant therapy for the treatment of TNBC (regardless of PD-L1 status).
In April 2020, the US FDA approved Immunomedics' antibody drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) for use in metastatic triple-negative breast cancer (mTNBC) that has previously received at least two therapies for metastatic disease Adult patients.
In November 2020, the US FDA approved Merck’s anti-PD-1 therapy Keytruda, combined with chemotherapy for the treatment of locally recurrent unresectable or metastatic TNBC patients whose tumors express PD-L1 (combined with a positive score [CPS] ≥ 10).
Original Source: Merck Receives Complete Response Letter From US FDA for Supplemental Biologics License application (sBLA) for KEYTRUDA® (pembrolizumab) in High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC)
