FDA approvals during the last 3 months
Closeup of medicines
During the last three months, the FDA approved several molecules and indications. In May, the following indications were approved:
Fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.
Azacitidine for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML).
Ivosidenib , combined with azacitidine for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test in adults 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy.
Tisagenlecleucel for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
In June 2022, the following indications were approved:
Dabrafenib in combination with trametinib for the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.
lisocabtagene maraleucel for adult patients with large B-cell lymphoma (LBCL) who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. It is not indicated for the treatment of patients with primary central nervous system lymphoma.
And finally, in July, the FDA approved crizotinib for adult and pediatric patients one year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT).
