The FDA granted approval for nivolumab for adjuvant treatment of some patients with melanoma, based on the results of the CHECKMATE-238 study.
Data from the phase 3 SPARTAN trial prompted the FDA's Priority Review designation for apalutamide.
FDA issues black box warning for rolapitant regarding the potential for anaphylaxis, anaphylactic shock, and other hypersensitivity reactions in patients receiving the injectable emulsion for CINV prophylaxis.
The FDA based its approval on data collected from the open-label, phase 2 CABOSUN study, for which researchers randomly assigned 157 patients with RCC to receive oral cabozantinib or sunitinib.
FDA grants Breakthrough Therapy designation for ribociclib as an initial endocrine-based therapy for HR+/HER2- breast cancer in premenopausal or perimenopausal women.
The US FDA approved pertuzumab in combination with trastuzumab and chemotherapy for adjuvant treatment of HER2-positive early breast cancer, and converted accelerated to full approval for the regimen as neoadjuvant therapy in certain breast cancers.
Ogivri was granted FDA approval to treat HER2 breast and gastric or gastroesophageal junction adenocarcinoma cancers.
The US FDA has granted regular approval to brentuximab vedotin (Adcetris) for pcALCL and CD30-expressing MF in adult patients who received prior systemic therapy.
Approval was based on results from ALEX, for which researchers randomly assigned 303 patients with ALK-positive NSCLC not previously treated with systemic therapy to receive alectinib or crizotinib.
Indications for vemurafenib are expanded to include BRAF V600 mutation-positive Erdheim-Chester disease, an extremely rare non-Langerhans cell histiocytosis. FDA approval is based on results from the phase 2 VE-BASKET study.
Why was the ESA APPRISE risk evaluation and mitigation strategy program discontinued?
Acalabrutinib is a treatment option for patients with mantle cell lymphoma who have not responded to prior treatment.
Bevacizumab-awwb is a recombinant IgG1 monoclonal antibody that works by binding to vascular endothelial growth factor (VEGF) and inhibits angiogenesis.
Gemtuzumab ozogamicin (Mylotarg) was granted US FDA approval for the treatment of relapsed or refractory CD-33 positive AML in patients ages 2 years and older and newly diagnosed CD-33 positive AML in adult patients.
The first FDA approval of a CAR T cell therapy is granted for the treatment of B-cell precursor ALL. FDA also approves rheumatoid arthritis medication for the management of cytokine release syndrome, a common and serious adverse effect of CAR T cell therapy
For adults with relapsed or refractory AML who have an IDH2 genetic mutation
Inotuzumab ozogamicin (Besponsa), an antibody-drug conjugate comprised of a monoclonal antibody that targets CD22 linked to the cytotoxic agent calicheamicin, was granted FDA approval for the treatment of R/R B-cell precursor ALL.
The FDA approved the indication expansion for ipilimumab based on evidence from 2 clinical trials evaluating its safety and efficacy in pediatric patients.
The US FDA has granted expanded clearance for the DigniCap Cooling System to include use in patients undergoing chemotherapy for solid tumors in other areas of the body besides the breast.
Patients aged 80 years and older had a cancer incidence of 16% in 2013 yet made up only 4% of cancer drug clinical trial participants during 2005-2015.
New safety issues are detected in almost one-third of drugs approved by the US FDA in the first 3 years after approval.
Rubraca (rucaparib) received accelerated approval by the U.S. Food and Drug Administration for the treatment of patients with previously treated BRCA-positive ovarian cancer.
Ceritinib has been granted Priority Review as a first-line treatment for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer.
First-in-class drugs are fast-tracked while follow-on drugs can take up to 15 years to be approved by the FDA.
Rucaparib has been approved for the treatment of patients with advanced ovarian cancer who harbor a deleterious BRCA mutation.
The US FDA has granted approval for additional indications for daratumumab for the treatment of patients with multiple myeloma who have received prior therapies.
Atezolizumab (Tecentriq) is approved by the FDA for the treatment of metastatic NSCLC in specific cases or tumors with EGFR or ALK gene mutations.
The US Food and Drug Administration has approved ofatumumab in combination with fludarabine and cyclophosphamide for the treatment of relapsed chronic lymphocytic leukemia (CLL).
US FDA standards demand that surrogate end points used in clinical trials be "reasonably likely to predict" survival for accelerated approval, or be established proxies for survival for traditional approval; however, surrogate end points used frequently lack formal study.
The US FDA has granted Priority Review to ofatumumab used in combination with fludarabine and cyclophosphamide for the treatment of chronic lymphocytic leukemia.
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