2020 drug approvals
Some notable 2020 FDA approvals of new drugs
- Tepezza (teprotumumab-trbw). Approved in January, Tepezza is the first and only FDA-approved treatment for thyroid eye disease, a rare and progressive inflammatory disease that affects the eye and nearby orbital tissues that can result in eye protrusion and visual impairment.
- Zeposia (ozanimod). Approved in March, Zeposia is a treatment for adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS, clinically isolated syndrome and active secondary progressive MS. Although it competes with Gilenya (fingolimod) and Mayzent (siponimod), the sphingosine-1-phosphate receptor modulator does not require first-dose monitoring for bradycardia (a slow heart rate).
- Evrysdi (risdiplam). Approved in August, Evrysdi is the first oral drug approved to treat spinal muscular atrophy (SMA). The two other drugs approved for some patients with SMA are Spinraza (nusinersen), administered as an intrathecal injection once every four months, and Zolgensma (onasemnogene abeparvovec-xioi), a gene therapy administered as a one-time IV injection.
Some notable 2020 FDA approvals of new oncology drugs
- Trodelvy (sacituzumab govitecan-hziy). Approved in April, Trodelvy is an antibody-drug conjugate for the treatment of patients with metastatic triple-negative breast cancer who received at least two prior therapies. The antibody “finds” the cancer, and the drug attacks the cancer.
- Zepzelca (lurbinectedin). Approved in June, Zepzelca is an alkylating drug for adult patients with metastatic small cell lung cancer who have progressed on or after chemotherapy.
- Sarclisa(isatuximab-irfc). Approved in March, Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells. The FDA approval is for Sarclisa in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies.
- Tabrecta (capmatinib). Approved in May, Tabrecta is a kinase inhibitor used to treat metastatic non-small cell lung cancer. It is one of an increasing number of agents that home in on cancer cells with a particular mutation, in this case a mutation that leads to MET exon 14 skipping.