FDA News

The FDA have granted an accelerated approval to acimibinib, which treats CML by binding to the ABL myristoyl pocket.

Atezolizumab is the first immunotherapy approved in the adjuvant setting to treat NSCLC.

Pembrolizumab is approved both in combination with chemotherapy, with or without bevacizumab, and as a single agent for the treatment of patients with recurrent or metastatic cervical cancer.

Abemaciclib is the first and only FDA approved CDK4/6 inhibitor to treat HR-positive, HER2-negative high-risk early breast cancer.

Brexucabtagene autoleucel is now an FDA approved treatment options for adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.

Cetuximab represents the first approved anti-EGFR antibody which, in combination with encorafenib, is now available to treat adults with pretreated metastatic CRC with a BRAF V600E mutation.

The FDA has granted cemiplimab-rwlc a priority review based on findings from the largest to-date, randomized clinical trial in advanced cervical cancer.

The FDA has approved ruxolitinib to treat adults with steroid-refractory chronic graft-versus-host disease.

The FDA approved tisotumab vedotin for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

The FDA has green lit mobocertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with an EGFR exon 20 insertion mutation.

Zanubrutinib received an accelerated approval for the indication of adults with marginal zone lymphoma with at least 1 prior treatment with an anti-CD20-based therapy.

Zanubrutinib (Brukinsa) is now FDA approved for the treatment of adults with Waldenström Macroglobulinemia.

Pembrolizumab has been granted full approval as a first-line treatment for a select population of patients with bladder cancer.

The Food and Drug Administration approved adjuvant nivolumab to treat urothelial carcinoma in patients who are at high risk of recurrence after undergoing radical resection, irrespective of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.

The regulatory decision is based on findings from collective data from the dMMR endometrial cancer cohort A1 and the dMMR solid-tumor, non-endometrial cancer, cohort F of the ongoing phase 1 GARNET trial (NCT02715284).

Belzutifan, a hypoxia-inducible factor inhibitor, has been approved for treatment of adults with cancers related to von Hippel-Lindau disease.

The FDA has determined that more data are necessary to certify the clinical benefit of retifanlimab for the treatment of squamous cell carcinoma of the anal canal.

The FDA has approved the first immunotherapy, pembrolizumab (Keytruda), to treat patients with high-risk early-stage triple-negative breast cancer.

The FDA has approved belumosudil for the treatment of patients aged 12 years and older with chronic graft-versus-host disease following failure of at least 2 prior lines of therapy.

The FDA approval of daratumumab plus hyaluronidase-fihj (Darzalex Faspro) plus pomalidomide and dexamethasone (Pd) was supported by data from the APOLLO trial.

“For the first time, physicians can treat advanced urothelial cancer following treatment with a platinum-containing therapy and immunotherapy using an FDA-approved therapy that has demonstrated an OS benefit compared with chemotherapy.”

The Food and Drug Administration has approved pembrolizumab for the treatment of patients with a locally advanced form of skin cancer.

The FDA has approved asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) as a complement of treatment for the most common childhood cancer.

177Lu-PSMA-617 receives a breakthrough therapy designation to treat patients with metastatic castration-resistant prostate cancer.

Gunagratinib (ICP-192), a potential therapeutic option for patients with cholangiocarcinoma, has been granted an orphan drug designation by the FDA.

The FDA granted a priority review for a Biologics License Application (BLA) to bastilimab for the treatment of recurrent or metastatic cervical cancer.

The FDA approved avapritinib (Ayvakit) for the treatment of adults with advanced systemic mastocytosis (AdvSM), including those with mast cell leukemia (MCL), aggressive systemic mastocytosism (ASM), or systemic mastocytosis with an associated hematological neoplasm (SM-AHN).

The FDA approved injectable technetium Tc 99m tilmanocept (Lymphoseek), a radiopharmaceutical agent that targets lymphatic mapping and guiding for sentinel lymph node biopsies (SLNB), for use in pediatric patients with melanoma, rhabdomyosarcoma, and other solid tumors.

The FDA has accepted the biologics license application for a proposed biosimilar for pegfilgrastim, which had been developed by Lupin Limited.

The FDA has granted a breakthrough therapy designation to teclistamab for the treatment of patients with relapsed/refractory multiple myeloma.