When the U.S. Food and Drug Administration approved tebentafusp-tebn (Kimmtrak®) in January 2022 as an orphan drug for unresectable or metastatic uveal melanoma in adults, it became the first—and only, at the time of this reference sheet’s publication—drug approved for the indication.
Growing evidence suggests that the gut microbiome, a diverse and complex mix of microorganisms and their metabolites, is closely linked to the immune system, and researchers are studying whether modulating the gut microbiome affects cancer immunotherapy treatment outcomes. In particular, probiotics—which are flora typically obtained through dietary sources such as yogurt and fermented foods or via supplemental forms—are gaining prominence as a potential strategy to modulate the gut microbiome during cancer treatment.
Biomarkers, also called molecular markers or signature molecules, can help clinicians characterize alterations in tumors through the detection of specific DNA, RNA, protein, or metabolomic profiles. These pieces of the cancer puzzle are part of precision oncology that the cancer care team can use to assess patients’ cancer risk and prognosis or monitor disease progression. Biomarkers are also a key factor in determining and tailoring treatment methods and their likelihood of success.
Many of our patients are individuals who haven’t developed cancer but might have a concerning family history of the disease. We rely on healthcare providers like oncology nurses to identify individuals with concerning cancer histories and refer them to genetic counselors for a complete risk assessment, including genetic testing when appropriate, to determine their risk and recommend proactive measures to reduce it.
After more than 93% of patients maintained nadir serum asparaginase activity in the therapy’s clinical trials, on June 30, 2021, the U.S. Food and Drug Administration approved asparaginase erwinia chrysanthemi (recombinant)–rywn (RylazeTM) for use as a component of a multiagent chemotherapeutic regimen for treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who have developed hypersensitivity to E. coli-derived asparaginase.
- FDA Approves Second Dosing Regimen for Asparaginase Erwinia Chrysanthemi (Recombinant)-Rywn
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- FDA Approves Brentuximab Vedotin in Combination With Chemotherapy for Pediatric Patients With Classical Hodgkin Lymphoma
- FDA Grants Accelerated Approval to Mirvetuximab Soravtansine-Gynx for FR Alpha–Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer