Articles

On September 15, 2021, the FDA accelerated the approval of mobocertinib (Exkivity; Takeda Pharmaceuticals), a tyrosine kinase inhibitor, for the treatment of adults with locally advanced or metastatic non−small-cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by the FDA-approved Oncomine Dx Target Test (Life Technologies Corporation), which was approved on the same day as a companion diagnostic for mobocertinib. The FDA granted mobocertinib priority review, breakthrough therapy designation, and orphan drug designation.

On July 16, 2021, the FDA approved belumosudil (Rezurock; Kadmon Holdings), a kinase inhibitor, for the treatment of patients aged ≥12 years with chronic graft-versus-host disease (GVHD) after failure of ≥2 previous lines of systemic therapy. The FDA granted belumosudil breakthrough therapy designation and priority review for this indication.

On August 31, 2021, the FDA approved zanubrutinib (Brukinsa; BeiGene), a Bruton tyrosine kinase (BTK) inhibitor, for the treatment of adults with Waldenström’s macroglobulinemia. Zanubrutinib was previously approved for the treatment of adults with mantle-cell lymphoma.

On August 25, 2021, the FDA approved ivosidenib (Tibsovo; Servier Pharmaceuticals), an oral IDH1 inhibitor, for the treatment of adults with previously treated, locally advanced or metastatic cholangiocarcinoma (CCA) and an IDH1 mutation, as detected by an FDA-approved test. The FDA granted ivosidenib a priority review for this indication and an orphan drug designation.

On August 10, 2021, the FDA approved the combination of lenvatinib (Lenvima; Eisai) plus pembrolizumab (Keytruda; Merck) for the first-line treatment of adults with advanced renal-cell carcinoma (RCC). The FDA granted this combination a priority review and breakthrough therapy designation.

On July 26, 2021, the FDA accelerated the approval of a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck) for the treatment of patients with high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as a neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

The recent release of EMPIRE-1 phase 2/3 trial results indicates the use of fluorine 18 fluciclovine PET/CT to guide salvage postprostatectomy radiotherapy increases event-free survival from biochemical recurrence or persistence.

Promising diagnostic and prognostic information with PSMA-based radioligands discussed in recently released review article.

Investigators released participant group data from a clinical trial looking at the use of fluorine 18 fluciclovine PET/CT in men with prostate cancer and biochemical recurrence to identify potential targets for therapy.

Updates on patient eligibility and methods from the INDICATE phase 3 trial were presented at the 2021 American Society of Clinical Oncology annual meeting.