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Issues
2022
October 2022, Vol 13, No 5
October 2022, Vol 13, No 5
COVID-19’s Impact on Radiation Oncology and Healthcare
By
Ben Adams
;
Ron DiGiaimo, MBA, FACHE
;
Bri Driggers
COVID-19 & Cancer
October 2022, Vol 13, No 5
Cancer growth and oncology care did not stop during the COVID-19 pandemic, and oncologists, healthcare workers, and patients came together to overcome challenges and produce incredible solutions that may be with us for many years.
Read More
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 More
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 More
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 More
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 More
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 More
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.
Read More
Retevmo Approved for Locally Advanced or Metastatic RET Fusion–Positive Solid Tumors and Locally Advanced or Metastatic RET Fusion– Positive NSCLC
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On
September 21, 2022
, the FDA accelerated the approval of selpercatinib (Retevmo; Eli Lilly), a
RET
kinase inhibitor, for the treatment of locally advanced or metastatic solid tumors with a
RET
gene fusion in patients whose disease has progressed while or after receiving systemic treatment or who have no alternative treatment options.
Read More
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.
Read More
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.
Read More
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Home
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Online First
Latest Issue
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Personalized Medicine
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