Over the past year, the U.S. Food and Drug Administration (FDA) granted approval to many novel drugs and new indications for older therapeutic agents used in oncology and hematology. Here is a comprehensive list of FDA approvals as of December 22, 2022.
❖ December
On December 22, mosunetuzumab-axgb (Lunsumio) was approved for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
On December 16, nadofaragene firadenovec-vncg (Adstiladrin), a nonreplicating adenoviral vector–based gene therapy, was approved for the treatment of adult patients with high-risk bacillus Calmette-Guérin–unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors.
On December 12, adagrasib (Krazati), a RAS GTPase family inhibitor, was approved for adult patients with KRAS G12C–mutated, locally advanced or metastatic non–small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
On December 9, atezolizumab (Tecentriq) was approved for the treatment of adult and pediatric patients aged 2 years and older with unresectable or metastatic alveolar soft-part sarcoma.
On December 1, olutasidenib (Rezlidhea) was approved for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation.
❖ November
On November 14, mirvetuximab soravtansine-gynx (Elahere) was approved for the treatment of patients with recurrent ovarian cancer that is resistant to platinum therapy.
❖ October
On October 25, teclistamab-cqyv (Tecvayli) was approved for the treatment of relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy.
On October 21, tremelimumab (Imjudo) was approved for the treatment of unresectable hepatocellular carcinoma.
❖ September
On September 30, futibatinib (Lytgobi) was approved for the treatment of intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or other rearrangements.
On September 21, approval was granted to selpercatinib (Retevmo) for adult patients with locally advanced or metastatic NSCLC with a RET gene fusion (as detected by an FDA-approved test). The FDA also approved the Oncomine Dx Target (ODxT) Test (Thermo Fisher Scientific) as a companion diagnostic for selpercatinib.
On September 20, sodium thiosulfate (Pedmark) was approved to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged 1 month and older with a localized (nonmetastatic) solid tumor.
ADVERTISEMENT
|
On September 17, cabozantinib (Cabometyx) was approved for the treatment of adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine–refractory or ineligible.
On September 9, eflapegrastim (Rolvedon) was approved to decrease the incidence of infection in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant incidence of febrile neutropenia.
On September 2, durvalumab (Imfinzi) in combination with gemcitabine and cisplatin was approved for the treatment of adult patients with locally advanced or metastatic biliary tract cancer.
❖ August
On August 26, pemigatinib (Pemazyre), a selective FGFR inhibitor, was approved for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement.
On August 24, ibrutinib (Imbruvica) was approved for the treatment of pediatric patients aged at least 1 year with chronic graft-vs-host disease after failure of one or more lines of systemic therapy.
On August 11, the FDA approved a label expansion for the Ventana MMR RxDx Panel, the first immunohistochemistry companion diagnostic test to aid in identifying patients whose solid tumors are deficient in DNA mismatch repair (dMMR) and who may be eligible for therapy with the PD-1 inhibitor pembrolizumab.
On August 10, capmatinib (Tabrecta) was approved for the treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have a mutation leading to MET exon 14 skipping, as detected by an FDA-approved test.
On August 5, darolutamide (Nubeqa) tablets in combination with docetaxel was approved for the treatment of adult patients with metastatic hormone-sensitive prostate cancer.
On August 5, fam-trastuzumab deruxtecan-nxki (Enhertu; T-DXd) was approved for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
❖ July
On July 14, crizotinib (Xalkori) was approved for the treatment of adult and pediatric patients aged 1 year and older with unresectable, recurrent, or refractory inflammatory ALK-positive myofibroblastic tumors.
❖ June
On June 24, the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (Breyanzi) was approved for the treatment of adult patients with large B-cell lymphoma who have disease refractory to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or disease refractory to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation due to comorbidities or age. It is not indicated for the treatment of patients with primary central nervous system lymphoma.
On June 23, dabrafenib (Tafinlar) plus trametinib (Mekinist) received accelerated approval for the treatment of adult and pediatric patients aged 6 years and older with unresectable or metastatic solid tumors with a BRAF V600E mutation whose disease has progressed following prior treatment and who have no satisfactory alternative treatment options. In accordance with the Accelerated Approval Program, continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
❖ May
On May 27, the FDA approved nivolumab (Opdivo) for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma in combination with fluoropyrimidine- and platinum-based chemotherapy, and in combination with ipilimumab.
On May 25, ivosidenib (Tibsovo) in combination with azacitidine was approved for the treatment of patients with newly diagnosed AML with a susceptible IDH1 mutation as detected by an FDA-approved test in adults aged 75 or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
On May 20, azacitidine (Vidaza) was approved for the treatment of pediatric patients with newly diagnosed juvenile myelomonocytic leukemia.