FDA News

Recent FDA approvals in oncology

The FDA has issued the following approvals for oncology indications:

  • Erdafitinib (Balversa, Janssen) received accelerated approval for the treatment of adults with locally advanced or metastatic bladder cancer that progressed during or following platinum-containing chemotherapy. This indication applies to patients who harbor FGFR3 or FGFR2 mutations according to the FDA-approved companion diagnostic device, therascreen FGFR RGQ RT-PCR Kit (QIAGEN Manchester);
  • Palbociclib (Ibrance, Pfizer) — a cyclin-dependent kinase 4/6 inhibitor — received expanded approval to include men with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial hormone-based therapy or in combination with fulvestrant;
  • Pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — received expanded approval to include the first-line treatment of patients with stage III non-small cell lung cancer who are not able to undergo surgical resection or definitive chemoradiation, as well as those with metastatic disease. The approval applies to patients with no EGFR or ALK genomic aberrations whose tumors express PD-L1, defined as tumor proportion score of 1% or greater as determined by an FDA-approved test;
  • Pembrolizumab also received approval for adjuvant treatment of patients who have melanoma with lymph node involvement who underwent complete resection, representing the first U.S. approval for pembrolizumab in the adjuvant setting and the fourth for skin cancer treatment; and
  • Trastuzumab-qyyp (Trazimera, Pfizer) received approval for the treatment of HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. Trastuzumab-qyyp is a monoclonal antibody biosimilar to trastuzumab (Herceptin, Genentech), which targets HER2.

To read more on these FDA actions and others, visit Healio.com/HemOnc and search for “FDA News.”

The FDA has issued the following approvals for oncology indications:

  • Erdafitinib (Balversa, Janssen) received accelerated approval for the treatment of adults with locally advanced or metastatic bladder cancer that progressed during or following platinum-containing chemotherapy. This indication applies to patients who harbor FGFR3 or FGFR2 mutations according to the FDA-approved companion diagnostic device, therascreen FGFR RGQ RT-PCR Kit (QIAGEN Manchester);
  • Palbociclib (Ibrance, Pfizer) — a cyclin-dependent kinase 4/6 inhibitor — received expanded approval to include men with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial hormone-based therapy or in combination with fulvestrant;
  • Pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — received expanded approval to include the first-line treatment of patients with stage III non-small cell lung cancer who are not able to undergo surgical resection or definitive chemoradiation, as well as those with metastatic disease. The approval applies to patients with no EGFR or ALK genomic aberrations whose tumors express PD-L1, defined as tumor proportion score of 1% or greater as determined by an FDA-approved test;
  • Pembrolizumab also received approval for adjuvant treatment of patients who have melanoma with lymph node involvement who underwent complete resection, representing the first U.S. approval for pembrolizumab in the adjuvant setting and the fourth for skin cancer treatment; and
  • Trastuzumab-qyyp (Trazimera, Pfizer) received approval for the treatment of HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. Trastuzumab-qyyp is a monoclonal antibody biosimilar to trastuzumab (Herceptin, Genentech), which targets HER2.

To read more on these FDA actions and others, visit Healio.com/HemOnc and search for “FDA News.”