Immunomedics’ Trodelvy (sacituzumab govitecan-hziy) Earns FDA Oncology Approval
Trodelvy: a new oncology product for breast cancer
Trodelvy is a landmark breast cancer drug
Oncologists now have another option to treat breast cancer patients. The FDA has approved Immunomedic’s Trodelvy (sacituzumab govitecan-hziy) with an indication for adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease.
Trodelvy is a monoclonal antibody
Trodelvy is targeted therapy in the form of a monoclonal antibody (mAb). Once administered to a patient, it aims for the protein called trop-2 that is often found on the surface of numerous types of solid tumors. It attaches itself to the tumor and administers a toxic chemotherapy metabolite known as irinotecan that destroys cancer cells by damaging their DNA.
It is the first FDA-approved antibody-drug conjugate that targets the Trop-2 antigen and the first antibody-drug conjugate approved by the FDA specifically for the treatment of relapsed or refractory metastatic triple-negative breast cancer.
Triple-negative breast cancer has an elevated level of treatment challenges
Triple-negative breast cancer does not have any of the receptors that are commonly found in breast cancer. Triple-negative breast cancer tests negative for estrogen receptors, progesterone receptors and excess HER2 protein. This means it is not fueled by estrogen and progesterone hormones or by HER2 protein. It can not be effectively treated with hormonal therapy drugs or therapies targeting HER2 protein receptors.
About 10–20% of breast cancers are categorized as triple-negative. This is one of the reasons why products like Trodelvy are so important. Trodelvy is developed to arm oncologists with a therapy that can overcome some of these challenges. Triple-negative breast cancer treatment typically involves a selection of these options:
Trodelvy was prioritized and issued its indication by the FDA through an accelerated approval based on its favorable response rate and response duration as demonstrated by the data Immunomedics submitted to the agency. The FDA granted Trodelvy orphan drug, fast track plus breakthrough therapy designation. Available by prescription only, Trodelvy is administered via infusion.
Business insights about Immunomedics
Founded in 1982, Immunomedics (NASDAQ: IMMU) is based in Morris Plains, New Jersey. The company has substantial experience and resources centered on antibody conjugation, antibody engineering, proprietary CDR-grafting methods, antibody production and formulation, immunochemistry, molecular biology, peptide chemistry, protein engineering and synthetic organic chemistry. It specializes in autoimmune and oncology therapeutic research and advanced product innovation.
The FDA continues to approve new and critically needed therapies
While COVID-19 engulfs the global healthcare community and numerous government authorities, the FDA continues to admirably fulfill its responsibilities. It is not only dealing with a viral pandemic it is evaluating a sizable number of advanced therapies. In the last several weeks it has approved:
- Aimmune Therapeutics Palforzia (arachis hypogaea)
- AstraZeneca’s and Merck’s Koselugo (selumetinib)
- Bristol Myers Squibb Opdivo (nivolumab) and Yervoy (ipilimumab)- (a 4th indication)
- Bristol Myers Squibb Zeposia (ozanimod)
- Seattle Genetics Tukysa (tucatinib)
- Seqirus Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted)
Its efforts are well worth it, the approval of Immunomedics’ Trodelvy therapy will be well received by metastatic triple-negative breast cancer patients and oncologists nationwide.
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