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Lymphoma
Zanubrutinib Superior to Ibrutinib in Patients with Relapsed or Refractory CLL/SLL
By
Phoebe Starr
ASH Highlights
,
Leukemia
,
Lymphoma
February 2023, Vol 14, No 1
A head-to-head phase 3 clinical trial in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) has found that zanubrutinib (Brukinsa), a next-generation Bruton tyrosine kinase (BTK) inhibitor, is more effective at preventing disease progression and better tolerated than ibrutinib (Imbruvica), a first-generation BTK inhibitor that has been the current standard of care for this population of patients.
Read Article
Brukinsa Now FDA Approved for Patients with CLL or SLL
FDA Approvals, News & Updates
,
Leukemia
,
Lymphoma
February 2023, Vol 14, No 1
On
January 19, 2023
, the FDA approved zanubrutinib (Brukinsa; BeiGene USA), a Bruton tyrosine kinase (BTK) inhibitor, for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The FDA granted zanubrutinib an orphan drug designation for this indication.
Read Article
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.
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.
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
Rylaze FDA Approved as Part of a Treatment Regimen for Leukemia or Lymphoma
FDA Approvals, News & Updates
,
Leukemia
,
Lymphoma
August 2021, Vol 12, No 4
On
June 30, 2021
, the FDA accelerated the approval of asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze; Jazz Pharmaceuticals), an asparagine-specific enzyme, as a component of a multidrug chemotherapy regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients aged ≥1 months with hypersensitivity to
Escherichia coli
–derived asparaginase. The FDA granted asparaginase erwinia a fast-track review and an orphan drug designation for this indication.
Read Article
Zynlonta First FDA-Approved CD19-Directed Therapy for Large B-Cell Lymphoma
FDA Approvals, News & Updates
,
Lymphoma
June 2021, Vol 12, No 3
On
April 23, 2021
, the FDA accelerated the approval of loncastuximab tesirine-lpyl (Zynlonta; ADC Therapeutics SA), an intravenous, CD19-directed antibody and alkylating agent conjugate, for the treatment of relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma, in adults who have received ≥2 lines of systemic therapy.
Read Article
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.
Read Article
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.
Read Article
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.
Read Article
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