The US Meals and Drug Administration (FDA) permitted a number of medication for brand spanking new indications in oncology final month.

The company granted first-time approval for Iwilfin (eflornithine), a brand new accelerated approval for Jaypirca (pirtobrutinib), and new indications for Welireg (belzutifan), Keytruda (pembrolizumab), and Padcev (enfortumab vedotin-ejfv).

The FDA additionally permitted the bevacizumab biosimilar Avzivi and a brand new on-body injector presentation of the pegfilgrastim biosimilar Udenyca. See the desk beneath for particulars on these approvals.

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Pharmacologic Class


Extra Data

Jaypirca (pirtobrutinib)

Kinase inhibitor

For the therapy of adults with power lymphocytic leukemia or small lymphocytic lymphoma who’ve acquired not less than 2 prior strains of remedy, together with a BTK inhibitor and a BCL2 inhibitor

Jaypirca Granted Accelerated Approval for CLL/SLL 

Iwilfin (eflornithine)

Ornithine decarboxylase inhibitor

To scale back the danger of relapse in grownup and pediatric sufferers with high-risk neuroblastoma who’ve had not less than a partial response to prior multiagent, multimodality remedy, together with anti-GD2 immunotherapy

Iwilfin, an Oral Upkeep Remedy for Excessive-Danger Neuroblastoma, Will get FDA Approval


Keytruda (pembrolizumab) and Padcev (enfortumab vedotin-ejfv)

Keytruda is a PD-1 blocking antibody, and Padcev is a Nectin-4-directed antibody and microtubule inhibitor conjugate

As mixture therapy for adults with domestically superior or metastatic urothelial most cancers

Keytruda Plus Padcev Authorized for Regionally Superior or Metastatic Urothelial Most cancers


Welireg (belzutifan)

Hypoxia-inducible issue inhibitor

For the therapy of adults with superior renal cell carcinoma who beforehand acquired a PD-1/L1 inhibitor and a VEGF tyrosine kinase inhibitor

Welireg Authorized for Superior Renal Cell Carcinoma


Udenyca Onbody (pegfilgrastim-cbqv)

An on-body injector presentation of Udenyca, a biosimilar to the leukocyte progress issue Neulasta

To lower the incidence of an infection, as manifested by febrile neutropenia, in sufferers with non-myeloid malignancies receiving myelosuppressive anticancer medication related to a clinically vital incidence of febrile neutropenia and to extend survival in sufferers acutely uncovered to myelosuppressive doses of radiation

FDA Approves On-Physique Injector Presentation of Udenyca


Avzivi (bevacizumab-tnjn)

Biosimilar to Avastin, a VEGF inhibitor

For the therapy of:

  • Metastatic colorectal most cancers, together with intravenous fluorouracil-based chemotherapy for first- or second-line therapy
  • Metastatic colorectal most cancers, together with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line therapy in sufferers who’ve progressed on a first-line bevacizumab-containing routine
  • Unresectable, domestically superior, recurrent, or metastatic nonsquamous non-small cell lung most cancers, together with carboplatin and paclitaxel for first-line therapy
  • Recurrent glioblastoma in adults
  • Metastatic renal cell carcinoma together with interferon alfa
  • Persistent, recurrent, or metastatic cervical most cancers, together with paclitaxel and cisplatin or paclitaxel and topotecan
  • Epithelial ovarian, fallopian tube, or main peritoneal most cancers, together with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent illness who acquired not more than 2 prior chemotherapy regimens

Bevacizumab Biosimilar Avzivi Receives FDA Approval