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FDA Approvals, News & Updates

FDA Approved Rylaze as Part of a Treatment Regimen for Young Patients with Leukemia or Lymphoma
FDA Approvals, News & UpdatesLeukemiaLymphoma
In June 2021, the FDA approved Rylaze (asparaginase erwinia chrysanthemi [recombinant]-rywn), an asparagine-specific enzyme, to be used as part of a multi-drug chemotherapy regimen for patients older than 1 month with acute lymphoblastic leukemia or lymphoblastic lymphoma who are hypersensitive to asparaginase caused by E. coli infection.
Darzalex Faspro Receives New FDA Indication, in Combination with Pomalyst and Dexamethasone, for the Treatment of Patients with Multiple Myeloma
FDA Approvals, News & UpdatesMultiple Myeloma
In July 2021, the FDA approved a new indication for Darzalex Faspro (daratumumab and hyaluronidase-fihj), for use in combination with Pomalyst (pomalidomide) and dexamethasone, for adults with multiple myeloma who have received at least 1 previous line of therapy.
Truseltiq Second Targeted Therapy Approved by the FDA for Patients with Advanced or Metastatic Cholangiocarcinoma and the FGFR2 Biomarker
CholangiocarcinomaFDA Approvals, News & Updates
In late May 2021, the FDA approved Truseltiq (infigratinib), a new targeted therapy, for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma and FGFR2 fusion or other rearrangement, as detected by an FDA-approved test.
Jemperli First Immunotherapy FDA Approved for Endometrial Cancer with dMMR Biomarker
Endometrial CancerFDA Approvals, News & UpdatesImmunotherapy
In April 2021, the FDA approved Jemperli (dostarlimab-gxly) for patients with recurrent or advanced endometrial cancer and the biomarker mismatch repair-deficient. This is the first immunotherapy approved for patients with this type of cancer.
Opdivo First Immunotherapy Approved for First-Line Therapy of Gastric Cancers
FDA Approvals, News & UpdatesGastric CancerImmunotherapy
In April 2021, the FDA approved Opdivo (nivolumab), for use with chemotherapy, as first-line treatment for patients with advanced or metastatic gastric cancer, including gastroesophageal junction cancer and esophageal adenocarcinoma.
Keytruda Another Immunotherapy Approved for First-Line Treatment of Advanced Gastric Cancer
FDA Approvals, News & UpdatesGastric CancerImmunotherapy
In May 2021, the FDA approved Keytruda (pembrolizumab), plus Herceptin and chemotherapy, for first-line treatment of locally advanced unresectable or metastatic, HER2-positive gastric or gastroesophageal junction adenocarcinoma. Keytruda is the second immunotherapy approved for gastric cancer.
Sarclisa Now Approved for Relapsed or Refractory Multiple Myeloma
FDA Approvals, News & UpdatesMultiple Myeloma
In March 2021, the FDA approved a new indication for Sarclisa (isatuximab-irfc), in combination with Kyprolis and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma.
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