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FDA Approvals, News & Updates
FDA Approvals, News & Updates
Lytgobi Receives Accelerated Approval for Cholangiocarcinoma
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On
September 30, 2022
, the FDA accelerated the approval of futibatinib (Lytgobi; Taiho Oncology), a tyrosine kinase inhibitor, for the treatment of previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (CCA) in adults with fibroblast growth factor receptor 2 (FGFR2) gene fusions or other arrangements.
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Tabrecta Receives Regular FDA Approval for Treatment of Metastatic NSCLC
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On
August 10, 2022
, the FDA accelerated the regular full approval of capmatinib (Tabrecta; Novartis), a tyrosine kinase inhibitor, for the treatment of metastatic non–small-cell lung cancer (NSCLC) in adults whose tumors have
MET
exon 13 skipping mutation, as detected by an FDA-approved test.
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Imfinzi Receives New Indication for Locally Advanced or Metastatic Biliary Tract Cancer
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On
September 2, 2022
, the FDA accelerated the approval of durvalumab (Imfinzi; AstraZeneca), a PD-L1–blocking antibody, in combination with gemcitabine and cisplatin, for the treatment of locally advanced or metastatic biliary tract cancer in adults.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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Home
Issues
Online First
Latest Issue
Issue Archive
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Personalized Medicine
Economics & Value
FDA Approvals, News & Updates
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View All Topics ›
Conference Correspondent
SABCS 2023 - HER2+ MBC
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Prostate Cancer Diagnostics Monthly Minutes
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