FDA Ends Summer With Surge of Activity

Oncology & Biotech News, September 2015, Volume 9, Issue 9

The FDA closed out summer 2015 by taking action on several oncology drug applications, approving new indications and granting several priority reviews.

OncLive Chairman,

Mike Hennessy

The FDA closed out summer 2015 by taking action on several oncology drug applications, approving new indications and granting several priority reviews.

Rolapitant (Varubi) is now approved for use in combination with other antiemetic agents to prevent delayed CINV from initial and repeat chemotherapy regimens, including highly emetogenic chemotherapy. Also in the area of CINV management, the FDA approved aprepitant capsules (Emend) in combination with other antiemetic agents for the prevention of acute and delayed nausea and vomiting in patients aged 12 to 17 and for those under the age of 12 who weigh at least 30 kg who are receiving moderately to highly emetogenic chemotherapy.

The antibody-drug conjugate brentuximab vedotin (Adcetris) was also approved by the FDA as a consolidation therapy following autologous stem cell transplantation (ASCT) in patients with Hodgkin lymphoma at risk of relapse or progression. Brentuximab vedotin was granted an accelerated approval in August 2011 as a treatment for patients with Hodgkin lymphoma after failure of ASCT or after failure of at least two prior chemotherapy regimens in patients who were not candidates for ASCT. The new indication moves treatment with the drug forward, as a therapy for patients who are at high risk of relapse following ASCT, and also converts the initial accelerated approval to a full approval.

In its ongoing effort to expedite the availability of novel therapies, the FDA issued several priority review designations, which mandate a shortened review period of ≤6 months. Among these drugs were two monoclonal antibodies for the treatment of multiple myeloma, elotuzumab (Empliciti) and daratumumab. Priority reviews were also granted to nivolumab (Opdivo) in nonsquamous non—small cell lung cancer (NSCLC), frontline pembrolizumab (Keytruda) in melanoma, and the intravesical immunotherapy MCNA for bladder cancer. Additionally, cabozantinib (Cometriq) received a breakthrough therapy designation in renal cell carcinoma and the FDA accepted an application for afatinib in squamous cell NSCLC.

As these drugs progressed through the standard FDA regulatory channel, the end of the summer also marked the dawn of the biosimilar era in the United States. Following a series of lawsuits and court decisions, the first FDA-approved biosimilar, Zarxio (filgrastim-sndz), is now available for patients. The G-CSF analog is approved by the FDA for all five authorized indications for its counterpart, Neupogen (filgrastim) under the newly initiated US biosimilar pathway.

The 300 μg dose of Zarxio will cost $275.66 and the 480 μg dose will cost $438.98. The historic price for Neupogen has been $324.30 and $516.45 for these same dose sizes, respectively, representing a 16.2% difference between the two drugs. As more biosimilars are approved, we will continue to update you on their impact on oncology drug pricing.

With several PDUFA dates for oncology drugs remaining, there remains a flurry of FDA activity yet to come in 2015. We look forward to bringing you the latest on these regulatory developments, as well as keeping you abreast of all the groundbreaking data presented at the year’s major remaining oncology meetings. As always, thank you for reading.