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FDA Approvals, News & Updates
FDA Approvals, News & Updates
Libtayo Receives 2 New Indications: For Basal-Cell Carcinoma and for NSCLC
FDA Approvals, News & Updates
April 2021, Vol 12, No 2
On
February 9, 2021
, the FDA approved a new indication for cemiplimab-rwlc (Libtayo; Regeneron/sanofi-aventis) for the treatment of locally advanced or metastatic basal-cell carcinoma (BCC) in patients who had received or are ineligible to receive a hedgehog inhibitor. The FDA granted cemiplimab a priority review and accelerated its approval for this indication.
Read Article
FDA Approves Tepmetko for Metastatic NSCLC and MET Exon 14 Skipping Alterations
FDA Approvals, News & Updates
,
Lung Cancer
February 2021, Vol 12, No 1
On
February 3, 2021
, the FDA accelerated the approval of oral tepotinib (Tepmetko; EMD Serono) for adults with metastatic non–small-cell lung cancer (NSCLC) harboring
MET
exon 14 (
MET
ex14) skipping alterations. This approval is for treatment-naïve patients as well as for patients who have received previous therapy. Tepotinib is the second
MET
inhibitor approved by the FDA and should be selected for treatment based on the presence of
MET
ex14. The FDA has granted tepotinib breakthrough therapy and orphan drug designations.
Read Article
Orgovyx First FDA-Approved Oral Hormone Therapy for Advanced Prostate Cancer
FDA Approvals, News & Updates
,
Prostate Cancer
February 2021, Vol 12, No 1
On
December 18, 2020
, the FDA approved relugolix (Orgovyx; Myovant Sciences), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of adults with advanced prostate cancer. Relugolix is the first oral androgen-deprivation therapy (ADT) and the first oral GnRH receptor antagonist approved for patients with advanced prostate cancer. The FDA granted relugolix priority review for this indication.
Read Article
FDA Approves Margenza for Treatment of Metastatic HER2-Positive Breast Cancer
Breast Cancer
,
FDA Approvals, News & Updates
February 2021, Vol 12, No 1
On
December 16, 2020
, the FDA approved margetuximab-cmkb (Margenza; MacroGenics) in combination with chemotherapy for the treatment of adults with metastatic HER2-positive breast cancer who have received ≥2 previous anti-HER2 regimens, of which at least 1 was for metastatic disease. The application for this approval received a fast-track designation.
Read Article
Xalkori Approved for Anaplastic Large-Cell Lymphoma and ALK Mutation in Young Patients
FDA Approvals, News & Updates
,
Lymphoma
February 2021, Vol 12, No 1
On
January 14, 2021
, the FDA approved crizotinib (Xalkori; Pfizer) for the treatment of young patients aged 1 to 21 years with relapsed or refractory systemic anaplastic large-cell lymphoma (ALCL) and
ALK
mutation. The safety and efficacy of crizotinib have not been established in older adults with this diagnosis. The FDA granted this application priority review and breakthrough therapy and orphan drug designations. Crizotinib was previously approved for patients with metastatic non–small-cell lung cancer and
ALK
or
ROS1
mutation.
Read Article
Tagrisso Approved as Adjuvant Therapy for NSCLC with EGFR Mutations
FDA Approvals, News & Updates
,
Lung Cancer
February 2021, Vol 12, No 1
On
December 18, 2020
, the FDA approved osimertinib (Tagrisso; AstraZeneca) for adjuvant therapy after tumor resection in patients with non–small-cell lung cancer (NSCLC) and
EGFR
exon 19 deletions or exon 21
L858R
mutations, as detected by an FDA-approved test. The FDA approved this application 2 months ahead of the FDA goal date and granted it a breakthrough therapy designation. Osimertinib was previously approved for the first-line treatment of metastatic NSCLC and
EGFR
exon 19 deletions or exon 21
L858R
mutations, and for the treatment of metastatic NSCLC and
EGFR
T790M mutation after
EGFR
tyrosine kinase inhibitor therapy.
Read Article
Xpovio Approved for Patients with Relapsed or Refractory Multiple Myeloma
FDA Approvals, News & Updates
,
Multiple Myeloma
February 2021, Vol 12, No 1
On
December 18, 2020
, the FDA approved selinexor (Xpovio; Karyopharm Therapeutics) in combination with bortezomib (Velcade) and dexamethasone for the treatment of adults with multiple myeloma after ≥1 previous therapies. The FDA granted this indication an orphan drug designation.
Read Article
FDA Approves First Prostate-Specific Membrane Antigen–Targeted PET Imaging Drug for Prostate Cancer
FDA Approvals, News & Updates
,
Prostate Cancer
December 2020, Vol 11, No 6
On
December 1, 2020
, the FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11; University of California), the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. Ga 68 PSMA-11 is indicated for men with suspected metastatic prostate cancer that may be curable by surgery or by radiation, and for suspected recurrent prostate cancer based on elevated serum prostate-specific antigen (PSA) levels.
Read Article
Danyelza Receives FDA Approval for High-Risk Neuroblastoma in the Bone and Bone Marrow
FDA Approvals, News & Updates
December 2020, Vol 11, No 6
On
November 25, 2020
, the FDA granted accelerated approval to naxitamab-gqgk (Danyelza; Y-mAbs Therapeutics), a GD2-binding monoclonal antibody, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow in pediatric patients aged ≥1 year and adults who achieved a partial response, minor response, or stable disease after receiving previous therapy. The FDA granted naxitamab priority review and breakthrough therapy, orphan drug, and rare pediatric disease designations.
Read Article
Oral Onureg First Drug Approved for Adults with AML in Remission
FDA Approvals, News & Updates
,
Leukemia
December 2020, Vol 11, No 6
On
September 1, 2020
, the FDA approved azacitidine (Onureg; Celgene), an oral nucleoside metabolic inhibitor, for maintenance treatment of adults with acute myeloid leukemia (AML) who had first complete remission (CR) or CR with incomplete blood count recovery after intensive induction chemotherapy and who are not candidates for intensive curative therapy. The FDA granted azacitidine an orphan drug designation and used its priority review for this indication.
Read Article
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