​FDA Approvals

 

 

Targeting a Rare Blood Cancer1166The molecularly targeted therapeutic tagraxofusp-erzs is the first ever treatment approved by the FDA for the treatment of blastic plasmacytoid dendritic cell neoplasm.2/14/2019 3:58:04 PM349https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1901088C_RareBloodCancer_150x190_1.jpg" style="BORDER&#58;0px solid;" />Targeting a Rare Blood CancerThe molecularly targeted therapeutic tagraxofusp-erzs is the first ever treatment approved by the FDA for the treatment of blastic plasmacytoid dendritic cell neoplasm.90
New Chemotherapy for Acute Lymphoblastic Leukemia Patients30811The FDA approval of calaspargase pegol-mknl provides a longer-acting chemotherapy option for certain patients with acute lymphoblastic leukemia.2/12/2019 8:08:39 PM242https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1901088A_ChemoforALL_TW_150x190_1.jpg" style="BORDER&#58;0px solid;" />New Chemotherapy for Acute Lymphoblastic Leukemia PatientsThe FDA approval of calaspargase pegol-mknl provides a longer-acting chemotherapy option for certain patients with acute lymphoblastic leukemia.89
Increasing Immunotherapy Options for Rare Skin Cancer742The FDA approval of pembrolizumab for treating certain patients with Merkel cell carcinoma makes it the second immunotherapeutic approved for treating this rare skin cancer.2/8/2019 2:10:12 PM338https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1901088B_MerkelCell_150x190_1.jpg" style="BORDER&#58;0px solid;" />Increasing Immunotherapy Options for Rare Skin CancerThe FDA approval of pembrolizumab for treating certain patients with Merkel cell carcinoma makes it the second immunotherapeutic approved for treating this rare skin cancer.88
Increasing Targeted Therapy Options for Leukemia Patients5576The FDA approval of gilteritinib provides a new treatment option for certain patients whose acute myeloid leukemia tests positive for a mutation in the FLT3 gene.1/25/2019 4:02:55 PM387https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1810031O_FDAapp_Myeloid_Thumb_150x190_1.jpg" style="BORDER&#58;0px solid;" />Increasing Targeted Therapy Options for Leukemia PatientsThe FDA approval of gilteritinib provides a new treatment option for certain patients whose acute myeloid leukemia tests positive for a mutation in the FLT3 gene. 87
FDA Approved the First Tissue-Agnostic Molecularly Targeted Therapeutic for Cancer5556The FDA approval makes larotrectinib the first molecularly targeted therapeutic approved for use based on a tumor biomarker rather than the site where the cancer originated.1/25/2019 2:37:11 PM379https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1810031S_FDAapp_TargetTherapy_Thumb_150x190_1.jpg" style="BORDER&#58;0px solid;" />FDA Approved the First Tissue-Agnostic Molecularly Targeted Therapeutic for CancerThe FDA approval makes larotrectinib the first molecularly targeted therapeutic approved for use based on a tumor biomarker rather than the site where the cancer originated.86
Targeting Leukemia in Older Patients5430The FDA recently approved two molecularly targeted therapeutics for treating patients newly diagnosed with acute myeloid leukemia (AML) who are 75 or older.1/24/2019 9:18:38 PM186https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1810031P_FDAapp_Glasdegib_Thumb_150x190_1.jpg" style="BORDER&#58;0px solid;" />Targeting Leukemia in Older PatientsThe FDA recently approved two molecularly targeted therapeutics for treating patients newly diagnosed with acute myeloid leukemia (AML) who are 75 or older.85
Expanding Immunotherapy Options for Liver Cancer Patients2879The FDA approval of pembrolizumab for treating certain patients with liver cancer makes it the second immunotherapeutic approved for this use.1/24/2019 4:14:27 PM291https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1810031R_FDAapp_Pembro_Thumb_150x190_1.jpg" style="BORDER&#58;0px solid;" />Expanding Immunotherapy Options for Liver Cancer PatientsThe FDA approval of pembrolizumab for treating certain patients with liver cancer makes it the second immunotherapeutic approved for this use.84
Targeting Metastatic Lung Cancer2356The U.S. Food and Drug Administration adds a fifth molecularly targeted therapeutic option for the treatment of ALK-positive lung cancer.1/24/2019 3:14:10 PM183https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1810031Q_FDAapp_Loriatinib_Thumb_150x190_1.jpg" style="BORDER&#58;0px solid;" />Targeting Metastatic Lung CancerThe U.S. Food and Drug Administration adds a fifth molecularly targeted therapeutic option for the treatment of ALK-positive lung cancer.83
New PARP Inhibitor Approved for Breast Cancer1321The FDA approval of talazoparib means there are now two PARP inhibitors that can be used to treat patients with breast cancer who have an inherited BRCA mutation.1/30/2019 5:06:30 PM953https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1810031N_FDAapp_Talazoparib_Thumb_150x190_1.jpg" style="BORDER&#58;0px solid;" />New PARP Inhibitor Approved for Breast CancerThe FDA approval of talazoparib means there are now two PARP inhibitors that can be used to treat patients with breast cancer who have an inherited BRCA mutation.82
New Immunotherapeutic Approved for Common Skin Cancer949The FDA decision makes cemiplimab-rwlc the first-ever treatment approved specifically for treating squamous cell carcinoma.1/30/2019 5:07:05 PM449https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1810031M_FDAapp_Immuno_SquamousCell_Thumb_150x190_1.jpg" style="BORDER&#58;0px solid;" />New Immunotherapeutic Approved for Common Skin CancerThe FDA decision makes cemiplimab-rwlc the first-ever treatment approved specifically for treating squamous cell carcinoma.79

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