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FDA Approvals, News & Updates
FDA Approvals, News & Updates
Pemazyre Now Approved for Relapsed or Refractory Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On
August 26, 2022
, the FDA accelerated the approval of pemigatinib (Pemazyre; Incyte Corporation), a tyrosine kinase inhibitor, for the treatment of relapsed or refractory myeloid/lymphoid neoplasms with fibroblast growth factor receptor (
FGFR
)1 rearrangement in adults.
Read Article
Imbruvica Now Approved for Treatment of Pediatric Patients with Chronic GVHD, Including New Oral Suspension Formulation
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On
August 24, 2022
, the FDA accelerated the approval of ibrutinib (Imbruvica; Pharmacyclics), a Bruton tyrosine kinase inhibitor, for the treatment of chronic graft-versus-host disease (GVHD) in pediatric patients aged ≥1 years who have not responded to ≥1 lines of systemic treatment.
Read Article
Enhertu First Drug Approved for HER2-Positive Non–Small- Cell Lung Cancer
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On
August 11, 2022
, the FDA accelerated the approval of fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo), a human epidermal growth factor 2 (
HER2
)-directed antibody and topoisomerase inhibitor conjugate, for the treatment of unresectable or metastatic non–small-cell lung cancer (NSCLC) in adults whose tumors have activating
HER2
(ERBB2) mutations, as detected by an FDA-approved test, and who have previously received systemic therapy.
Read Article
FDA Accelerates the Approval of Enhertu for the Treatment of HER2-Low Breast Cancer
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On
August 5, 2022
, the FDA accelerated the approval of fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo), a human epidermal growth factor 2 (
HER2
)-directed antibody and topoisomerase inhibitor conjugate, for the treatment of unresectable or metastatic
HER2
-low (immunohistochemistry [IHC]1-positive or IHC2-positive/in situ hybridization–negative) breast cancer in adults who have previously received chemotherapy in the metastatic setting or who have had disease recurzrence during or within 6 months of completing adjuvant chemotherapy.
Read Article
Nubeqa Now Approved for Metastatic Hormone- Sensitive Prostate Cancer
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On
August 5, 2022
, the FDA accelerated the approval of darolutamide (Nubeqa; Bayer Healthcare), an androgen receptor inhibitor, in combination with docetaxel, for the treatment of metastatic hormone-sensitive prostate cancer in adults. Darolutamide was previously approved for the treatment of nonmetastatic castration-resistant prostate cancer.
Read Article
Kymriah Receives Accelerated FDA Approval for Relapsed or Refractory Follicular Lymphoma
FDA Approvals, News & Updates
June 2022, Vol 13, No 3
On May 27, 2022, the FDA accelerated the approval of a new indication for the CD19-directed CAR T-cell therapy tisagenlecleucel (Kymriah; Novartis) for adults with relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy.
Read Article
Tibsovo Receives a New Indication, in Combination with Vidaza, for Newly Diagnosed Patients with AML and IDH1 Mutation
FDA Approvals, News & Updates
June 2022, Vol 13, No 3
On May 25, 2022, the FDA accelerated the approval of ivosidenib tablets (Tibsovo; Servier Pharmaceuticals), in combination with azacitidine tablets (Onureg; Celgene) for newly diagnosed acute myeloid leukemia (AML) and a susceptible
IDH1
mutation, as detected by an FDA-approved test, in patients aged ≥75 years, or patients with comorbidities that preclude the use of intensive induction chemotherapy.
Read Article
Vidaza Now Approved for Patients with Newly Diagnosed Juvenile Myelomonocytic Leukemia
FDA Approvals, News & Updates
June 2022, Vol 13, No 3
On May 20, 2022, the FDA accelerated the approval of a new indication for azacitidine injection (Vidaza; Celgene) for the treatment of pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML).
Read Article
FDA Grants Enhertu Regular Approval for Patients with Unresectable or Metastatic Breast Cancer
FDA Approvals, News & Updates
June 2022, Vol 13, No 3
On
May 4, 2022
, the FDA granted a regular full approval for fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo), an
HER2
-directed antibody and topoisomerase inhibitor conjugate, for the treatment of adults with unresectable or metastatic
HER2
-positive breast cancer who had received a prior anti–
HER2
-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and who had developed disease recurrence during or within 6 months of completing therapy.
Read Article
Yescarta First CAR T-Cell Therapy FDA Approved for Patients with Large B-Cell Lymphoma
FDA Approvals, News & Updates
June 2022, Vol 13, No 3
On April 1, 2022, the FDA accelerated the approval of a new indication for the CAR T-cell therapy axicabtagene ciloleucel (Yescarta; Kite Pharma) for adults with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.
Read Article
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