The United States Food and Drug Agency (US FDA) is the world’s leading organisation for drug approvals. MediPaper offers you insight in the US FDA approvals for oncology and haematology drugs, as reported by the US FDA – in real time.

Biosimilar epoetin alfa-epbx approved by FDA for the treatment of anemia due to chronic kidney disease, use of zidovudine for HIV, and concomitant myelosuppressive chemotherapy

 

  • On May 14, 2018 the FDA announced approval of biosimilar epoetin alfa-epbx (Retacrit®, Hospira, a subsidiary of Pfizer) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. Epoetin alfa-epbx is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Retacrit® is a biosimilar of Epogen/Procrit (epoetin alfa, Amgen).

FDA approves dabrafenib plus trametinib for anaplastic thyroid cancer with BRAF V600E mutation

 

  • FDA approves dabrafenib plus trametinib for anaplastic thyroid cancer with BRAF V600E mutation. More Information. May 4, 2018.

Tisagenlecleucel CAR-T receives additional FDA Approval for DLBCL

Tisagenlecleucel CAR-T receives additional FDA Approval for DLBCL

  • FDA approved tisagenlecleucel (KYMRIAH, Novartis Pharmaceuticals Corp.) a CD19-directed genetically modified autologous T-cell immunotherapy, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. More Information.

See all CAR-T therapies and indications

 

FDA granted regular approval to dabrafenib and trametinib in combination for the adjuvant treatment of patients with BRAF V600E or V600K melanoma

 

  • FDA granted regular approval to dabrafenib (TAFINLAR, Novartis Pharmaceuticals Corp.) and trametinib (MEKINIST, Novartis Pharmaceuticals Corp.) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.  More Information.

FDA approved osimertinib for the 1st-line treatment of patients with EGFR exon 19 deletions or exon 21 L858R mutations positive metastatic non-small cell lung cancer (NSCLC)

 

  • FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.  More Information.

FDA approved fostamatinib disodium hexahydrate tablets for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP)

 

  • FDA approved fostamatinib disodium hexahydrate tablets (TAVALISSE, Rigel Pharmaceuticals, Inc.) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. More Information.

FDA granted approvals to nivolumab plus ipilimumab for the treatment of intermediate or poor risk, previously untreated advanced RCC

 

FDA approved everolimus tablets for oral suspension for adjunctive treatment of adult and pediatric TSC-associated partial-onset seizures

  • FDA  granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma. More Information.  April 16, 2018
  • FDA approved rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer

     

    • FDA approved rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer. More Information.

    FDA granted accelerated approval to blinatumomab for the treatment of adult and paediatric patients with B-cell precursor ALL in first or second complete remission with MRD ≥0.1%

     

    FDA approved nilotinib for paediatric patients with newly diagnosed Ph+ CML-CP or Ph+ CML-CP resistant or intolerant to prior TKI

     

    • FDA approved nilotinib (TASIGNA, Novartis Pharmaceuticals Corporation) for pediatric patients 1 year of age or older with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. More Information.  March 22, 2018

    FDA approved brentuximab vedotin plus chemotherapy for untreated stage III or IV classical Hodgkin lymphoma (cHL)

     

    • FDA  approved brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. More Information.

    FDA approved abemaciclib plus aromatase inhibitor for untreated postmenopausal women with HR-positive HER2-negative advanced or metastatic breast cancer

     

    • FDA approved abemaciclib (VERZENIO, Eli Lilly and Company) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. More Information.

    FDA approved durvalumab as maintenace for unresectable stage III NSCLC responding to platinum-based chemoradiation therapy

     

    • FDA approved durvalumab (Imfinzi, AstraZeneca Inc.) for patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. More Information.

    FDA approves apalutamide for non-metastatic castration-resistant prostate cancer

     

    • FDA approves apalutamide for non-metastatic castration-resistant prostate cancer. More Information.

    FDA approved abiraterone acetate tablets plus prednisone for metastatic high-risk CSPC

     

    • FDA approved abiraterone acetate (Zytiga, Janssen Biotech Inc.) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC). More Information.

    FDA approved lutetium Lu 177 dotatate for the treatment of somatostatin receptor-positive GEP-NETs

     

    • FDA approved lutetium Lu 177 dotatate (LUTATHERA, Advanced Accelerator Applications USA, Inc.) a radiolabeled somatostatin analogue, for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumours in adults. More Information.

    FDA granted regular approval to olaparib in the treatment of (suspected) deleterious germline BRCA-mutated, HER2-negative MBC

     

    • FDA granted regular approval to olaparib tablets (Lynparza, AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting. More Information

     

    FDA approved a broadened indication of afatinib in the 1st-line treatment of metastatic NSCLC with non-resistant EGFR mutations

     

    • FDA granted approval to afatinib (Gilotrif, Boehringer Ingelheim Pharmaceutical, Inc.) for a broadened indication in 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.  More Information.