Enter the field of breast cancer! Mercadon Keytruda (Corrida) 2 applications were accepted by the FDA for treatment of triple-negative breast cancer (TNBC)!

!--webeditor:page title"--/ Merck and Co recently announced that the U.S. Food and Drug Administration (FDA) has accepted anti-PD-1 therapy Keytruda (Corrida, generic name: pembrolizumab, PaboliJusa) to treat three negative breast cancer (TNBC) 2 new supplementary biological licenses (TNBC).
FDA has granted one of the sBLA priority reviews, which seeks to expedite approval of Keytruda combined chemotherapy for the treatment of local recurrent non-recitability or metastatic TNBC patients with tumor expression PD-L1 (combined positive score of 10).
fda has designated the sBLA's Prescription Drug User Charge Act (PDUFA) target date as November 28, 2020.
the FDA will conduct a standard review of another sBLA that seeks approval for Keytruda for use in high-risk early TNBC patients, specifically for the use of Keytruda combined chemotherapy for new preoperative complementary therapy, and then as a single drug for postoperative assisted therapy.
FDA has designated the PUDFA target date for the sBLA as March 29, 2021. "TNBC is an invasive disease and there is an urgent need for new treatment options," said Dr. Roy Baynes, Senior Vice President and Head of Global Clinical Development at
's Mercado Research Laboratory.
FDA's acceptance of Keytruda's applications is an important step in helping early and metastatic People with TNBC disease.
these sBAs also mark Keytruda's first application searly in the United States to treat breast cancer.
we look forward to working closely with the FDA to bring these new options to patients as soon as possible.
" the two sBAs are based on data from the Third Session keynote-355 Study (NCT02819518) and The Third Session of the KEYNOTE-522 Study (NCT00336488), respectively.
KEYNOTE-355: A randomized, double-blind trial that evaluated the efficacy and safety of Keytruda plus chemotherapy, placebo-chemotherapy for first-line treatment of TNBC patients.
the trial, chemotherapy was one of three: nab-yew alcohol, yew alcohol, gisythamine/kap.
data showed that in patients with tumor expression PD-L1 and combined positive score (CPS) of 10 (38 percent of the study population), Keytruda-chemotherapy resulted in significant lysonless and clinical lysy compared to placebo and chemotherapy (cpc.) Median PFS: 9.7 months vs 5.6 months), significantly reduced the risk of disease progression or death by 35% (HR-0.65; 95% CI: 0.49-0.86; p-0.0012).
as mentioned earlier, and on the recommendation of the Independent Data Monitoring Board (DMC), the study will continue without any changes to assess the total lifetime of another dual primary endpoint (OS).
KEYNOTE-522: A randomized, double-blind trial conducted in high-risk early TNBC patients evaluating the use of Keytruda combined chemotherapy, placebo combined chemotherapy for new preoperative complementary therapy, followed by Keytruda and placebo for postoperative assisted therapy.
data show that during the new auxiliary treatment period, regardless of PD-L1 expression, Keytruda plus chemotherapy (n-401) showed a significant increase in statistical significance in pathological complete remission (pCR) (pCR: 64.8% vs 51.2%, p-0.00055) compared to chemotherapy (n-201).
in the case of another major endpoint event-free survival (EFS), the median follow-up was 15.5 months, and the Keytruda programme showed a favourable trend in EFS compared to the chemotherapy-placebo regimen, reducing the risk of recurrence of the new auxiliary disease progression and auxiliary period by 37% (HR-0.63 (95% CI: 0.43-0.93) compared to the chemotherapy-place programme.
note that, based on the data from this study, Keytruda is the first anti-PD-1 therapy to show a statistically significant statistically significant improvement in PCR as a new complementary therapy for TNBC (regardless of PD-L1 status).
previously, the FDA has granted Keytruda plus chemotherapy the Breakthrough Drug Qualification (BTD) for new complementary treatments in early-stage TNBC patients.
Keytruda is an anti-PD-(L) 1 tumor immunotherapy that helps detect and fight tumor cells by boosting the body's immune system.
Keytruda is an anti-PD-1 therapy that activates T lymphocytes that may affect tumor cells and healthy cells by blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2.
to date, Keytruda has been approved for treatment of more than 10 types of cancer.
globally, more than 10 anti-PD-(L)1 treatments have been approved for the market, led by Keytruda, with global sales of $11.1 billion in 2019, up 58 percent from the previous year.
, A report by Evaluate Pharma, a pharmaceutical market research firm, predicts that Keytruda will have sales of $24.91 billion in 2026, making it the world's best-selling drug.
, and 100-times Mesi Quip anti-PD-1 therapy Opdivo (Odivo, Navuliu monotonica) sales will reach $12.677 billion, making it the world's second-best-selling drug.
breast cancer is the most common type of cancer in women, with more than 2 million cases diagnosed worldwide each year.
TNBC accounts for about 15-20% of all breast cancers, and Isitn is more common among women under 50 than other types of breast cancer.
TNBC refers specifically to estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2) are all negative expression of breast cancer, which is an invasive breast cancer, rapid progress, poor prognosis, high recurrence rate, 5-year survival rate of less than 15%.
TNBC's ineffectiveness with hormone therapy and HER2 targeted therapy, such as Herceptin, has limited clinical options, relying mainly on chemotherapy.
metastatic TNBC is one of the most aggressive and difficult to treat breast cancer.
!--/ewebeditor:!--.ewebeditor:page title"--TNBC New Drug, In March 2019, the FDA approved Roche's anti-PD-L1 therapy Tecentriq (Tesanchi, generic name: atezolieb, Atzhuzumab) first-line treatment for PD-L1 anti-statiental or advanced partial metastweism.
approval, making the Tecentriq-Abraxane combination the first cancer immune treatment for PD-L1-positive metastatic TNBC.
in Phase III IMpassion130 study, the Tecentriq-Abraxane program significantly reduced the risk of disease progression or death by 40% in PD-L1-positive patients compared to the placebo-Abraxane programme (median PFS: 7.4 months vs 4.8 months, HR 0.60, 95 %CI: 0.48-0.77, p 0.0001), resulting in a 7-month clinical improvement in total survival (OS) (median OS: 25.0 vs 18.0 months, HR-0.71, 95% CI: 0.54-0.93).
April, the FDA approved The ADC's antibody drug Trodelvy (sacituzumab govitecan-hziy) for metastatic triple-negative breast cancer (mTNBC) adult patients who have previously received at least two treatments to treat metastatic diseases.
note, Trodelvy is the first FDA-approved ADC drug specifically to treat relapsed or refractable mTNBC, and the first FDA-approved anti-Trop-2 ADC drug.
data from the single-arm multicenter II IMMU-132-01 study showed that in adult patients with over-treatment of metastatic diseases previously treated with multiple therapies (range: 2-10), the objective remission rate (ORR) was 33.3% (95% CI: 24.6), and the median duration of remission (DOR) was 7.7 months (95 percent). original source of
() Merck Announces Two US Regulatory Milstas for KEYTRUDa (pembrolizumab) in Triple-Negative Breast Cancer (TNBC) !--/ewebeditor.