The approvals mark advances in the treatment of several major types of cancer.On Oct. 23, the FDA approved trabectedin (sold as Yondelis®) for the treatment of certain soft-tissue sarcomas.
On Nov. 13, the agency approved osimertinib (sold as TagrissoTM) for patients with non-small cell lung cancer (NSCLC) that carries a specific genetic mutation.
(( Image : Bruce Johnson, MD )) .
In rapid succession over the next two weeks came FDA approvals of daratumumab (DarzalexTM), ixazomib (Ninlaro®), and elotuzumab (EmplicitiTM) for patients with multiple myeloma.
FDA approval means that patients who meet certain criteria can receive the drugs as part of standard therapy.
The Dana-Farber-led science and testing of these agents covered the full range of drug development – from earliest discovery and phase 1 studies, in which novel agents are tested for the first time in human patients, to large-scale 3 clinical trials, in which the agents' safety and effectiveness are compared to that of standard therapies.
Most of the new drugs are the first of their kind to be approved for these specific types of cancer:
Trabectedin is a naturally-derived targeted chemotherapy drug that binds to DNA in a unique way, thereby slowing and stopping cancer cells from multiplying;
Osimertinib targets an abnormal enzyme that causes some NSCLC cells to become resistant to other smart drugs;
Daratumumab and elotuzumab are the first monoclonal antibodies approval for myeloma; each targets specific cell-surface receptors to spark an immune system attack on myeloma;
Ixazomib is a new pill form of a proteasome inhibitor, which prevents myeloma cells from breaking down excess proteins, leading to the self-destruction of the cancer cells.
"The FDA approval of these five different agents in three different cancers demonstrates the breadth and depth of the ongoing research at Dana-Farber," said Chief Clinical Research Officer Bruce Johnson, MD.
"The work is a testament to the commitment of our staff to meaningful scientific discoveries and to the idea that tomorrow holds even greater promise for our patients and families."
Success in clinical testingTrabectedin is the first new drug approved for patients with liposarcoma (cancers of fat cells) since the 1970s. It was also approved for patients with leiomyosarcoma, a cancer of the uterus and other smooth muscle cells. Together, these malignancies account for nearly half all cases of soft-tissue sarcoma.
Previous trials led by George Demetri, MD, director of the Center for Sarcoma and Bone Oncology at Dana-Farber, led to the approval of trabectedin as a standard treatment for sarcomas outside the United States. Demetri then directed the phase 3 trial that prompted FDA approval. The study showed that trabectedin was significantly better than an older chemotherapy drug at controlling these cancers.
"FDA approval marks a meaningful event for patients, built upon years of research, offering hope for people living with two of the most common subtypes of this serious disease, where there are limited available alternatives," Demetri said. "We're now exploring the use of precision medicine to identify patients who may have the most durable benefit with this new agent, sometimes lasting for years.
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