US FDA Onc\Haem Approvals – Page 7 – Medical News Asia

FDA safety alert: use of immunotherapy in metastatic urothelial cancer with low PD-L1 expression

18 May 2018/2 Comments/in US FDA Onc\Haem Approvals, Uncategorised/by Stijn van den Borne, MSc

On May 18, the United States (US) Food and Drug Administration (FDA) issued an alert about the decreased survival in studies with pembrolizumab (Keytruda®) and atezolizumab (Tecentriq®) as single agent first-line therapy for patients with metastatic urothelial cancer (mUCC) and low expression of the programmed death ligand 1 (PD-L1) protein.

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

16 May 2018/1 Comment/in US FDA Onc\Haem Approvals, Uncategorised/by scienterrific

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 daratumumab plus VMP for transplant ineligible myeloma patients

7 May 2018/0 Comments/in US FDA Onc\Haem Approvals, Uncategorised/by Stijn van den Borne, MSc

On 7 May 2018 the US FDA approved daratumumab (DARZALEX®) in combination with the VMP regimen (bortezomib (VELCADE®), melphalan, and prednisone) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

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

4 May 2018/0 Comments/in US FDA Onc\Haem Approvals, Uncategorised/by scienterrific

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

1 May 2018/0 Comments/in US FDA Onc\Haem Approvals, Immunotherapy/by scienterrific

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

Adjuvant dabrafenib plus trametinib FDA approved for BRAF V600E or V600K melanoma

30 April 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Oncology, Melanoma & Skin Cancer/by scienterrific

The FDA granted regular approval to dabrafenib (Tafinlar®, Novartis) and trametinib (Mekinist®, Novartis) 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.

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)

19 April 2018/0 Comments/in US FDA Onc\Haem Approvals, Lung Cancer, Oncology, Targeted Therapies, Translational Research/by scienterrific

edit+xClone Element

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.

Frontline nivolumab plus ipilimumab approved for intermediate or poor risk advanced RCC

16 April 2018/0 Comments/in Genitourinary Cancer, US FDA Onc\Haem Approvals, Oncology, Immunotherapy/by scienterrific

The FDA granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.

Everolimus suspension approved in TSC-associated partial-onset seizures

10 April 2018/0 Comments/in Genitourinary Cancer, US FDA Onc\Haem Approvals, Oncology/by scienterrific

On April 10, the FDA approved everolimus tablets for oral suspension (Afinitor Disperz®, Novartis) for the adjunctive treatment of adult and pediatric patients ≥2 years with tuberous sclerosis complex (TSC)-associated partial-onset seizures.

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

6 April 2018/0 Comments/in US FDA Onc\Haem Approvals, Uncategorised/by scienterrific

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