Approval was granted for the treatment of patients with unresectable or metastatic BRAF V600E or V600K mutation-positive melanoma.
The 18-month progression-free survival rate was 71.6% among patients treated with daratumumab plus VMP compared with 50.2% among patients treated with VMP alone.
Duvelisib, a first-in-class dual inhibitor of PI3K-delta and -gamma, was evaluated in patients with relapsed/refractory CLL/SLL and in patients with refractory indolent non-Hodgkin lymphoma.
The US FDA granted approval based on results from ARIEL3, a randomized clinical trial conducted with 561 eligible cancer patients.
Accelerated approval was granted by the FDA based on the results of a single-arm trial.
FDA grants approval to immunotherapy combination in the treatment of unresectable and metastatic BRAF V600E mutation-positive anaplastic thyroid cancer (ATC).
Enfortumab vedotin was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA), based on interim results from a Phase 1 study.
FDA approval was granted based on findings from the open-label phase 3 ECHELON-1 study.
The US FDA approved expanding the indications for the agent to include pediatric and adult patients with B-cell precursor ALL who have minimal residual disease during or after treatment.
FDA Fast Track designation was supported by data from a Phase 2 study reviewing pamrevlumab in combination with gemcitabine and nab-paclitaxel.
Based on results of 2 prospective studies, the FDA approved the use of nilotinib in pediatric patients older than 1 year with newly diagnosed Ph+ CML-CP and those with TKI-intolerant or resistant disease.
According to the FDA, the drug approval is the first to use the end point of metastasis-free survival.
What is being done to address shortages of chemotherapy drugs?
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.
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