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Issues
2021
April 2021, Vol 12, No 2
April 2021, Vol 12, No 2
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.
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Lorbrena Receives FDA Approval for First-Line Treatment of Metastatic Lung Cancer
FDA Approvals, News & Updates
April 2021, Vol 12, No 2
On
March 3, 2021
, the FDA approved a new indication for lorlatinib (Lorbrena; Pfizer), a third-generation
ALK
inhibitor, for the first-line treatment of patients with non–small-cell lung cancer (NSCLC) and
ALK
mutation.
Read More
Yescarta First CAR T-Cell Therapy FDA Approved for Follicular Lymphoma
FDA Approvals, News & Updates
,
Lymphoma
April 2021, Vol 12, No 2
On
March 5, 2021
, the FDA approved a new indication for axicabtagene ciloleucel (Yescarta; Kite Pharma), a chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients with relapsed or refractory follicular lymphoma (FL) who have received ≥2 lines of systemic therapy. The FDA granted this indication a priority review as well as breakthrough therapy and orphan drug designations.
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Vyxeos Now Indicated for Treatment of Pediatric Patients with AML
FDA Approvals, News & Updates
,
Leukemia
April 2021, Vol 12, No 2
On
March 30, 2021
, the FDA approved a new indication for daunorubicin and cytarabine (Vyxeos; Jazz Pharmaceuticals) for the treatment of pediatric patients aged ≥1 years with newly diagnosed, therapy-related acute myeloid leukemia (AML) or patients with AML and myelodysplasia-related changes. Daunorubicin and cytarabine is a liposomal combination of an anthracycline topoisomerase inhibitor (daunorubicin) and a nucleoside metabolic inhibitor (cytarabine).
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FDA Approved Ukoniq, New Targeted Therapy, for Marginal-Zone Lymphoma and Follicular Lymphoma
FDA Approvals, News & Updates
,
Lymphoma
April 2021, Vol 12, No 2
On
February 5, 2021
, the FDA approved umbralisib (Ukoniq; TG Therapeutics), an oral kinase inhibitor, for the treatment of adults with relapsed or refractory marginal-zone lymphoma (MZL) or with relapsed or refractory follicular lymphoma (FL). Umbralisib is indicated for MZL after ≥1 CD20-directed regimens, and for FL after ≥3 lines of systemic therapy.
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FDA Approved Breyanzi, Novel CAR T-Cell Therapy, for Large B-Cell Lymphoma
FDA Approvals, News & Updates
,
Lymphoma
April 2021, Vol 12, No 2
On
February 5, 2021
, the FDA approved lisocabtagene maraleucel (Breyanzi; Juno Therapeutics), a new CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adults with relapsed or refractory large B-cell lymphoma (LBCL) after ≥2 previous lines of systemic therapy. The FDA granted lisocabtagene maraleucel priority review, as well as breakthrough therapy, orphan drug, and regenerative medicine advanced therapy designations.
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Cosela First CDK4/6 Inhibitor FDA Approved to Reduce Chemotherapy-Induced Myelosuppression
FDA Approvals, News & Updates
April 2021, Vol 12, No 2
On
February 12, 2021
, the FDA approved trilaciclib (Cosela; G1 Therapeutics), as a first-in-class cyclin-dependent kinase (CDK)4/6 inhibitor to reduce the frequency of chemotherapy-induced myelosuppression in adults with extensive-stage small-cell lung cancer, when used before a platinum plus etoposide regimen or a topotecan-containing regimen. Trilaciclib may prevent damage to bone marrow cells by inhibiting the CDK4/6 enzyme. The FDA granted trilaciclib priority review and a breakthrough therapy designation.
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FDA Approved Pepaxto for Relapsed or Refractory Multiple Myeloma
FDA Approvals, News & Updates
,
Multiple Myeloma
April 2021, Vol 12, No 2
On
February 26, 2021
, the FDA accelerated the approval of melphalan flufenamide (Pepaxto; Oncopeptides AB), an alkylating drug, for the treatment, in combination with dexamethasone, of adults with relapsed or refractory multiple myeloma who have received ≥4 lines of therapy and whose disease is triple-refractory to ≥1 proteasome inhibitors, 1 immunomodulatory drug, and 1 CD-38–directed monoclonal antibody.
Read More
Belzutifan: Novel Approach to Advanced RCC
By
Phoebe Starr
ASCO 2021 Highlights
April 2021, Vol 12, No 2
Belzutifan, an oral, novel hypoxia-inducible factor (HIF)-2α inhibitor, showed encouraging activity as a single agent in heavily pretreated patients with advanced clear-cell renal-cell carcinoma (RCC) associated with von Hippel-Lindau (VHL) disease, as well as impressive tumor shrinkage when used in combination with cabozantinib (Cabometyx) in separate studies presented at the 2021 ASCO Genitourinary Cancers Symposium.
Read More
Final Results from ClarIDHy: Ivosidenib Extends Survival in Patients with Cholangiocarcinoma and IDH1 Mutation
By
Wayne Kuznar
ASCO 2021 Highlights
,
Cholangiocarcinoma
April 2021, Vol 12, No 2
Final results from the phase 3 clinical trial ClarIDHy showed that ivosidenib (Tibsovo), a first-in-class oral inhibitor of isocitrate dehydrogenase 1 (
IDH1
) mutation, prolonged the median overall survival (OS) in patients with previously treated advanced cholangiocarcinoma (CCA) and
IDH1
mutation. Although this improvement did not reach statistical significance, after adjusting for crossovers from the placebo to the ivosidenib group, the difference in median OS was statistically significant.
Read More
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Home
Issues
Online First
Latest Issue
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Browse By Topic
Personalized Medicine
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