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FDA Approvals, News & Updates
FDA Approvals, News & Updates
Orserdu FDA Approved for ER-Positive, Advanced or Metastatic Breast Cancer with ESR1 Mutation
FDA Approvals, News & Updates
,
Breast Cancer
February 2023, Vol 14, No 1
On
January 27, 2023
, the FDA approved elacestrant (Orserdu; Stemline Therapeutics), an estrogen receptor (ER) antagonist, for the treatment of postmenopausal women or adult men with ER-positive,
HER2
-negative advanced or metastatic breast cancer and an
ESR1
mutation whose disease progressed after ≥1 line of endocrine therapy.
Read Article
FDA Grants Lunsumio Accelerated Approval for Relapsed or Refractory Follicular Lymphoma
FDA Approvals, News & Updates
,
Lymphoma
February 2023, Vol 14, No 1
On
December 22, 2022
, the FDA accelerated the approval of mosunetuzumab-axgb (Lunsumio; Genentech), a bispecific CD20-directed CD3 T-cell engager, for adults with relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy. The FDA granted this indication breakthrough therapy and orphan drug designations.
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Jaypirca Receives FDA Accelerated Approval for Relapsed or Refractory Mantle-Cell Lymphoma
FDA Approvals, News & Updates
,
Lymphoma
February 2023, Vol 14, No 1
On
January 27, 2023
, the FDA accelerated the approval of pirtobrutinib (Jaypirca; Eli Lilly) for the treatment of patients with relapsed or refractory mantle-cell lymphoma (MCL) after at least 2 lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
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Imjudo, a New CTLA-4 Inhibitor, FDA Approved in Combination with Imfinzi for Unresectable HCC
FDA Approvals, News & Updates
,
Hepatocellular Carcinoma
December 2022, Vol 13, No 6
On
October 21, 2022
, the FDA approved tremelimumab (Imjudo; AstraZeneca), a CTLA-4 monoclonal antibody, in combination with durvalumab (Imfinzi; AstraZeneca), a PD-L1 inhibitor, for the treatment of adults with unresectable hepatocellular carcinoma (HCC). The FDA granted tremelimumab an orphan drug designation for this indication.
Read Article
Adcetris plus Chemotherapy Now FDA Approved for Pediatric Patients with Classical Hodgkin Lymphoma
FDA Approvals, News & Updates
,
Lymphoma
December 2022, Vol 13, No 6
On
November 10, 2022
, the FDA approved brentuximab vedotin (Adcetris; Seagen) in combination with a chemotherapy regimen of doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVEPC) for treatment-naïve pediatric patients aged ≥2 years with high-risk classical Hodgkin lymphoma. This is the first indication for brentuximab vedotin for pediatric patients. Brentuximab vedotin has an orphan drug designation for Hodgkin lymphoma.
Read Article
Imjudo FDA Approved with Imfinzi and Chemotherapy for Metastatic NSCLC
FDA Approvals, News & Updates
,
Lung Cancer
December 2022, Vol 13, No 6
Two weeks after the initial approval of tremelimumab (Imjudo; AstraZeneca), a CTLA-4 monoclonal antibody, on
November 10, 2022
, the FDA approved this new immunotherapy, in combination with the PD-L1 inhibitor durvalumab (Imfinzi; AstraZeneca) and platinum-based chemotherapy, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC) and no
EGFR
or
ALK
genomic alterations.
Read Article
Tecvayli, First Bispecific BCMA-Directed CD3 T-Cell Engager, Received FDA Approval for Relapsed or Refractory Multiple Myeloma
FDA Approvals, News & Updates
,
Multiple Myeloma
December 2022, Vol 13, No 6
On
October 25, 2022
, the FDA accelerated the approval of teclistamab-cqyv (Tecvayli; Janssen Biotech), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who received ≥4 previous lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. The FDA granted teclistamab breakthrough therapy and orphan drug designations.
Read Article
Elahere, First FRα-Directed Antibody, FDA Approved for FRα-Positive, Platinum-Resistant Ovarian Cancer
FDA Approvals, News & Updates
,
Ovarian Cancer
December 2022, Vol 13, No 6
On
November 14, 2022
, the FDA accelerated the approval of mirvetuximab soravtansine-gynx (Elahere; ImmunoGen), an intravenous folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate, for the treatment of adults with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1 to 3 previous systemic treatments, regardless of previous use of bevacizumab (Avastin). Patients should be identified for treatment with mirvetuximab soravtansine by an FDA-approved test.
Read Article
Rezlidhia New IDH1 Inhibitor FDA Approved for Relapsed or Refractory AML with IDH1 Mutation
FDA Approvals, News & Updates
,
Leukemia
December 2022, Vol 13, No 6
On
December 1, 2022
, the FDA approved olutasidenib (Rezlidhia; Forma Therapeutics) capsules, an oral
IDH1
inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) and a susceptible
IDH1
mutation, as detected by an FDA-approved test.
Read Article
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 Article
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