More information. December 21, This new product provides for a longer interval between doses compared to other available pegaspargase products. More Information. December 20, December 19, November 28, November 26, December 27, December 3, FDA granted accelerated approval to voxelotor Oxbryta, Global Blood Therapeutics for adults and pediatric patients 12 years of age and older with sickle cell disease.
FDA Expands Approval of Fulvestrant for Advanced Breast Cancer
HDR is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression greater than six months after response to the last platinum-based chemotherapy. September 26, Apalutamide was initially approved in for patients with non-metastatic castration-resistant prostate cancer. August 2, FDA approves pembrolizumab for advanced esophageal squamous cell cancer. July 30, FDA granted accelerated approval to selinexor XPOVIO, Karyopharm Therapeutics in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma RRMM who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
July 3, June 17, March 18, FDA approves atezolizumab for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer.
February 22, Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib. October 16, September 28, In addition, duvelisib received accelerated approval for adult patients with relapsed or refractory follicular lymphoma FL after at least two prior systemic therapies.
August 20, FDA approved two different companion diagnostic tests, one for use with Keytruda and one for use with Tecentriq, More Information.
August 16, July 31, July 30, June 27, FDA granted accelerated approval to pembrolizumab Keytruda, Merck for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma PMBCL , or who have relapsed after two or more prior lines of therapy.
It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
May 4, May 1, April 10, FDA approved rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer. February 16, FDA approves apalutamide for non-metastatic castration-resistant prostate cancer. December 22, FDA granted regular approval to hydroxyurea Siklos, Addmedica to reduce the frequency of painful crises and the need for blood transfusions in pediatric patients from 2 years of age and older with sickle cell anemia with recurrent moderate to severe painful crises.
December 20, FDA granted regular approval to the anti-PD1 monoclonal antibody, nivolumab OPDIVO, Bristol-Myers Squibb Company for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. Nivolumab was previously approved for the treatment of patients with unresectable or metastatic melanoma.
FDA Approved: How the FDA Approval Process Works
November 9, November 6, More Inforrmation. Mvasi is the first biosimilar approved in the U. Gemtuzumab ozogamicin may be used in combination with daunorubicin and cytarabine for adults with newly-diagnosed AML, or as a stand-alone treatment for certain adult and pediatric patients.
August 30, FDA granted regular approval to olaparib tablets Lynparza, AstraZeneca for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.
May 9, FDA granted accelerated approval to durvalumab IMFINZI, AstraZeneca UK Limited for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This is the first FDA-approved product to treat this type of cancer.
February 22, FDA granted accelerated approval to nivolumab OPDIVO, Bristol-Myers Squibb Company for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.
October 24, FDA granted accelerated approval to olaratumab LARTRUVO, Eli Lilly and Company for the treatment of patients with soft tissue sarcoma STS not amenable to curative treatment with radiotherapy or surgery and with a histologic subtype for which an anthracycline-containing regimen is appropriate. The currently approved recommended dosage regimens were modified to mg intravenously IV every two weeks.
September 13, Atezolizumab is a programmed death-ligand 1 PD-L1 blocking antibody.
May 18, FDA granted accelerated approval to nivolumab Opdivo, marketed by Bristol-Myers Squibb for the treatment of patients with classical Hodgkin lymphoma cHL that has relapsed or progressed after autologous hematopoietic stem cell transplantation HSCT and post-transplantation brentuximab vedotin Adcetris.
Lenvatinib was first approved in for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. March 30, March 11, FDA approved everolimus Afinitor , Novartis for the treatment of adult patients with progressive, well-differentiated non-functional, neuroendocrine tumors NET of gastrointestinal GI or lung origin with unresectable, locally advanced or metastatic disease.
Obinutuzumab was previously approved for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia. Ofatumumab was previously approved for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy was considered inappropriate and also for patients with CLL refractory to fludarabine and alemtuzumab.
Approval Based on Improved Progression-Free Survival
January 19, To view archived approval information, please see the FDA Archive. Users are able to get automatic updates on news items on new approvals, meetings, and other announcements. Email Address.