3 new FDA drug approvals

FDA approved 3 major drugs to treat lung cancer, prostate cancer, and cystic fibrosis.

Here are the top 3 new drug approvals:

• Apalutamide (Erleada, Janssen) is the first FDA-approved treatment for patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). Erleada received FDA Priority Review designation after a phase 3 study demonstrated a 72% reduction in risk of distant metastasis or death, and an increase in median metastasis-free survival (MFS) by more than two years (difference of 24.31 months) in patients with NM-CRPC.

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“The need to delay metastasis is critical to the treatment of prostate cancer. Nearly 90% of patients with castration-resistant prostate cancer will eventually develop bone metastases, at which point the prognosis sharply worsens,” said Mathai Mammen, MD, PhD, global head of Janssen Research & Development, in a statement from the company. “We are excited about what this approval means for patients living with prostate cancer, and that physicians now have an important and much-needed treatment option that has been shown to delay the progression of castration-resistant prostate cancer.”

In the phase 3 trial, the median MFS was 40.51 months for Erleada, compared to 16.2 months for the placebo, prolonging MFS by more than 2 years.

    2.  Durvalumab (Imfinzi, AstraZeneca) was approved to treat patients with stage 3 non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).

“This is the first treatment approved for stage 3 unresectable non-small cell lung cancer to reduce the risk of the cancer progressing, when the cancer has not worsened after chemoradiation,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a statement from FDA.

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For patients with stage 3 lung cancer that cannot be removed surgically, the current approach to prevent progression is chemoradiation, according to Pazdur. “Although a small number of patients may be cured with the chemoradiation, the cancer may eventually progress. Patients now have an approved therapy that has been shown to keep the cancer from progressing for a longer time after chemoradiation,” he said.

The approval of Imfinzi was based on a randomized trial of 713 patients whose cancer had not progressed after completing chemotherapy and radiation. The trial measured the length of time the tumors did not have significant growth after starting treatment with Imfinzi or a placebo (progression-free survival).

The median progression-free survival for patients taking Imfinzi was 16.8 months compared to 5.6 months for patients receiving a placebo.

    3.  Tezacaftor/ivacaftor and ivacaftor (Symdeko, Vertex Pharmaceuticals) was approved to treat  the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have 2 copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or who have at least 1 mutation that is responsive to tezacaftor/ivacaftor.

Vertex is already shipping the drug to pharmacies in the United States, and the company expects approval in the EU in the second half of 2018.

“Today is an exciting day for the CF community. The approval of Symdeko, our third disease-modifying CF medicine, offers many patients an important new treatment option,” said Jeffrey Leiden, MD, PhD, chairman, president and CEO of Vertex, in.a statement from the company. “This approval is an important milestone in our journey to treat every person with CF, and we remain committed to urgently advancing our efforts to develop new medicines that treat the underlying cause of CF for the many people still waiting.”

The approval of Ymdeko was based on two phase 3 studies that demonstrated that patients experienced statistically significant and clinically meaningful improvements in lung function and other measures of disease, with a favorable safety profile. 

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