ICYMI: 5 Most Recent FDA Approvals, June 23, 2020


The FDA has had a busy couple of weeks, approving new agents to treat a variety of cancers.

As spring turns to summer, the FDA is not slowing down in approving drugs in the oncology space — some for very specific cancer types, and others (such as the recent approval of pembrolizumab) for a whole range of solid tumors that have a high mutational burden.

In case you missed it, here is a list of the 5 most recent FDA approvals:

  • Selinexor for relapsed/refractory diffuse large Bcell lymphoma (DLBCL). The approval is for patients with this subtype of nonHodgkin lymphoma who have had 2 or more prior therapies.
  • Tazemetostat for relapsed/refractory follicular lymphoma. This drug was also approved for patients who have had at least 2 prior therapies, or for those with relapsed/refractory follicular lymphoma who have no other satisfactory treatment options available.
  • Pembrolizumab for tumor mutational burdenhigh solid tumors. The immunotherapy agent’s approval is for both pediatric and adult patients with solid tumors whose disease has at least 10 mutations/megabase.
  • Gemtuzumab ozogamicin for pediatric acute myeloid leukemia. Children aged 1 month or older can now be treated with gemtuzumab ozogamicin if their disease is CD33—positive.
  • Lurbinectedin for metastatic small cell lung cancer. The approval is for patients with small cell lung cancer whose disease progressed after a platinumbased chemotherapy.

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