​FDA Approvals

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Expanding the Use of a CAR T-cell Immunotherapy1959The FDA decision means tisagenlecleucel (Kymriah) is now approved for certain types of non-Hodgkin lymphoma and acute lymphoblastic leukemia.5/25/2018 2:43:58 PM196https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1801021J_Kymirah_150x190_1.jpg" style="BORDER&#58;0px solid;" />Expanding the Use of a CAR T-cell ImmunotherapyThe FDA decision means tisagenlecleucel (Kymriah) is now approved for certain types of non-Hodgkin lymphoma and acute lymphoblastic leukemia.66
Combining Immunotherapy for Kidney Cancer1928The FDA has approved a combination of ipilimumab and nivolumab for treating intermediate- or poor-risk, previously untreated advanced renal cell carcinoma5/25/2018 2:04:18 PM145https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1801021K_FDA_ComboImmuno_KidCan_150x190_1.jpg" style="BORDER&#58;0px solid;" />Combining Immunotherapy for Kidney CancerThe FDA has approved a combination of ipilimumab and nivolumab for treating intermediate- or poor-risk, previously untreated advanced renal cell carcinoma65
Combining Targeted Therapies for Lung Cancer8591An FDA-approved precision medicine treatment is for certain patients with metastatic lung cancer with a specific BRAF mutation.5/22/2018 6:20:11 PM197https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1707043_ComboLung_Headshot_150x190_1.jpg" style="BORDER&#58;0px solid;" />Combining Targeted Therapies for Lung CancerAn FDA-approved precision medicine treatment is for certain patients with metastatic lung cancer with a specific BRAF mutation.64
Confronting Stage 3 Lung Cancer With Immunotherapy6246The FDA approval of the immunotherapeutic durvalumab makes it the first treatment approved to reduce the risk of stage 3 lung cancer progressing.3/23/2018 1:19:19 PM656https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1801021H_Duvalumab_150x190_1.jpg" style="BORDER&#58;0px solid;" />Confronting Stage 3 Lung Cancer With ImmunotherapyThe FDA approval of the immunotherapeutic durvalumab makes it the first treatment approved to reduce the risk of stage 3 lung cancer progressing. 63
Keeping Prostate Cancer at Bay4069A new hormone therapy is the first treatment to be approved because it was found to markedly delay the spread of prostate cancer to other sites in the body.3/22/2018 6:57:37 PM425https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1801021G_Prostate_150x190_1.jpg" style="BORDER&#58;0px solid;" />Keeping Prostate Cancer at BayA new hormone therapy is the first treatment to be approved because it was found to markedly delay the spread of prostate cancer to other sites in the body. 62
Preventing Bone Complications for Multiple Myeloma Patients1299The FDA has expanded the use of a molecularly targeted therapeutic to include patients with multiple myeloma.2/26/2018 1:42:05 PM687https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1801021D_Myeloma_150x190_1.jpg" style="BORDER&#58;0px solid;" />Preventing Bone Complications for Multiple Myeloma PatientsThe FDA has expanded the use of a molecularly targeted therapeutic to include patients with multiple myeloma.61
First Targeted Therapeutic for BRCA-mutant Breast Cancer5311The FDA has approved the molecularly targeted therapeutic olaparib for treating patients who have HER2-negative breast cancer and who inherited a BRCA1 or BRCA2 mutation.2/15/2018 5:01:56 PM628https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1801021E_Olaparib_150x190_1.jpg" style="BORDER&#58;0px solid;" />First Targeted Therapeutic for BRCA-mutant Breast CancerThe FDA has approved the molecularly targeted therapeutic olaparib for treating patients who have HER2-negative breast cancer and who inherited a BRCA1 or BRCA2 mutation.60
Expanding Molecularly Targeted Therapy to Additional Types of Lymphoma2060The FDA has expanded the use of a CD30-targeted antibody–drug conjugate to include two additional types of lymphoma.12/13/2017 3:20:36 PM1151https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1711053_LymphDrug_150x190_1.jpg" style="BORDER&#58;0px solid;" />Expanding Molecularly Targeted Therapy to Additional Types of LymphomaThe FDA has expanded the use of a CD30-targeted antibody–drug conjugate to include two additional types of lymphoma.59
Targeting a Rare Blood Cancer2043The molecularly targeted therapeutic vemurafenib is the first ever treatment approved by the FDA for treating Erdheim-Chester disease.12/13/2017 2:35:00 PM698https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1711052_EChester_150x190_1.jpg" style="BORDER&#58;0px solid;" />Targeting a Rare Blood CancerThe molecularly targeted therapeutic vemurafenib is the first ever treatment approved by the FDA for treating Erdheim-Chester disease.58
A New Molecularly Targeted Therapeutic for Non-Hodgkin Lymphoma28599The newly approved therapeutic is for certain patients with an aggressive type of non-Hodgkin lymphoma called mantle cell lymphoma.11/21/2017 8:11:11 PM1939https://www.aacrfoundation.org/approvals/Pages/Forms/AllItems.aspxhtmlFalseaspx<img alt="" src="/PublishingImages/FDA%20approvals/1711027A_MantleCell_150x190_1.jpg" style="BORDER&#58;0px solid;" />A New Molecularly Targeted Therapeutic for Non-Hodgkin LymphomaThe newly approved therapeutic is for certain patients with an aggressive type of non-Hodgkin lymphoma called mantle cell lymphoma.57

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