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Medical World News: Regulatory Updates

FDA Approves Cemiplimab-rwlc to Treat Second Most Common Skin Cancer

The FDA has approved the immune checkpoint inhibitor cemiplimab-rwlc, to be sold as Libtayo, for the treatment of metastatic cutaneous squamous cell carcinoma (CSCC) or in patients with locally advanced CSCC who are not candidates for curative surgery or curative radiation.

CSCC is the second most common form of skin cancer and is responsible for nearly 7000 deaths each year in the United States. To date, the cancer accounts for an estimated 20% of all skin cancers in the United States, with the number of patients with the disease expected to rise on an annual basis.

Developed in conjunction by Regeneron Pharmaceuticals and Sanofi, cemiplimab-rwlc is a monoclonal antibody that targets the immune checkpoint receptor PD-1. According to Regeneron, this is the first and only treatment specifically approved and available for advanced CSCC in the United States.

The “FDA decision is great news for patients with advanced CSCC who previously had no approved treatment options....Libtayo is an important new immunotherapy option for US physicians to help address a significant unmet need in this patient group,” said Michael R. Migden, MD, lead investigator in the CSCC clinical program and professor in the departments of Dermatology and Head and Neck Surgery at The University of Texas MD Anderson Cancer Center.

Cemiplimab-rwlc was evaluated under the FDA’s priority review pathway and was granted breakthrough therapy designation status for advanced CSCC in 2017. The recommended dosage of cemiplimab-rwlc is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks, until disease progression or unacceptable toxicity.

In the United States, the wholesale acquisition cost of the treatment is $9100 per 3-week treatment cycle; however, Regeneron and Sanofi noted that “the actual costs to patients are generally anticipated to be lower, as the list price does not reflect insurance coverage, copay support, or financial assistance from patient support programs.”

“In the United States, CSCC accounts for 1 in 5 skin cancers, and the number of new diagnoses is increasing. We believe Libtayo has the potential to make a difference for US patients with advanced CSCC, as it helps to fill a critical gap in treatment options,” said Olivier Brandicourt, MD, CEO of Sanofi.

REFERENCE:

1. FDA approves Libtayo (cemiplimab-rwlc) as first and only treatment for advanced cutaneous cell carcinoma [press release]. Tarrytown, NY, and Paris, France: PR Newswire; September 28, 2018. prnewswire.com/news-releases/ fda-approves-libtayo-cemiplimab-rwlc-as-first-and-only-treatment-for-advanced-cutaneous-squamous-cell-carcino- ma-300721188.html. Accessed October 15, 2018.

FDA Gives Speedy Approval to Brentuximab Vedotin for Peripheral T-cell Lymphoma

The FDA announced recently that it expanded the approved use of brentuximab vedotin (Adcetris) in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL), using a new review process designed to increase efficiency.

It is also the first FDA approval for the treatment of newly diagnosed PTCL. PTCLs are rare, fast-growing non-Hodgkin lymphomas that develop from T-cells, which spread quickly and are hard to treat. T-cell lymphomas account for between 10% and 15% of all non-Hodgkin lymphomas, according to the Leukemia and Lymphoma Society.

The pilot program under which the drug was approved, Real-Time Oncology Review (RTOR), allows the FDA to review much of the data after the clinical trial results become available and before the information is formally submitted to the FDA. The pilot focuses on early submission of data that are most relevant to assessing the safety and efficacy of a product.

The approval of brentuximab vedotin for PTCL is the fourth time the RTOR has been used, according to an FDA spokesperson.

“When the sponsor submits the completed application, the review team will already be familiar with the data and be able to conduct a more efficient, timely, and thorough review,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products, in a statement.1

Brentuximab vedotin is an antibody drug conjugate. Earlier this month, an analysis found that it was cost-effective2 when combined with chemotherapy as frontline treatment for stage III or IV classical Hodgkin lymphoma.

The new approval was based on a clinical trial of 452 patients with certain PTCLs who received either brentuximab plus chemotherapy or a standard chemotherapy (CHOP) as first-line treatment. Progression-free survival was significantly longer (hazard ratio, 0.71; P = .01) in the brentuximab arm (median = 48 months vs 21 months with CHOP). Overall survival and overall response rates were also significantly better in the brentuximab arm.

The drug, sold by Seattle Genetics, had also received priority review and breakthrough therapy designation.

“By participating in the FDA’s Real-Time Oncology Review process and working closely with the FDA, we are now able to make the Adcetris regimen available to previously untreated patients with CD30-expressing PTCL in an unprecedented less than 2 weeks after submission of our supplemental BLA,” said Clay Siegall, PhD, the firm’s president and chief executive officer of Seattle Genetics, in a statement.3

The most common adverse effects of brentuximab plus chemotherapy included peripheral neuropathy, nausea and vomiting, diarrhea, low white blood cell counts, fatigue, mouth sores, constipation, hair loss, fever, and anemia.

REFERENCES:

1. FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot [press release]. Washington, DC: FDA; November 16, 2018. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626079. htm?. Accessed November 16, 2018.

2. Caffrey M. Authors find brentuximab vedotin cost-effective for treatment of advanced Hodgkin lymphoma. The American Journal of Managed Care® website. www.ajmc.com/newsroom/authors-find-brentuximab-vedotin-costeffective-for-treatment-of-advanced-hodgkin-lymphoma. Published October 31, 2018. Accessed November 16, 2018.

3. Seattle Genetics announces FDA approval of ADCETRIS® (brentuximab vedotin) in combination with chemo- therapy for adults with previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas [press release]. Bothell, WA: November 16, 2018. www.businesswire.com/news/ home/20181116005332/en/Seattle-Genetics-Announces-FDA-Approval-ADCETRIS®-Brentuximab. Accessed November 16, 2018.

 

New Melanoma Guidelines Identify Recommended Treatments, Weigh In on Genetic Testing

New guidelines released by the American Academy of Dermatology (AAD) will help physicians provide the best treatment for more than 1 million Americans living with melanoma, the deadliest form of skin cancer. The guidelines were published1 on Thursday, November 1, in the Journal of the American Academy of Dermatology.

“Guidelines of care for the management of primary cutaneous melanoma” outlines best practices for treating the disease and was developed by a work group of dermatologists, oncologists, and other experts.

“Melanoma is the deadliest form of skin cancer, and we hope these guide- lines will help dermatologists and other physicians enhance their delivery of life-saving treatment to patients,” board-certified dermatologist Susan M. Swetter, MD, FAAD, co-chair of the work group that developed the guidelines, said in a statement.2 “In order to provide the best possible resource for practitioners, we reviewed the latest scientific data and addressed certain topics that weren’t covered in the AAD’s previous melanoma guidelines.”

Although melanoma is the deadliest skin cancer, current treatments are curative if the disease is detected early enough. The 5-year survival rate is 99% if melanoma is detected early and treated before it spreads to the lymph nodes.

The guidelines review biopsy techniques for lesions suggestive of melanoma; histopathologic interpretation of cutaneous melanoma; use of laboratory, molecular, and imaging tests, as well as follow-up for asymptomatic patients; treatment recommendations, including surgical and nonsurgical options; and the latest data regarding pregnancy and melanoma, genetic testing, and management of toxicities related to novel targeted agents and immunotherapies.

According to the guidelines, patients with a family history of melanoma should receive education and counseling regarding their genetic risk, but formal genetic testing may not always be appropriate. The guidelines recommend that genetic testing be considered on an individual basis after counseling.

Surgical excision is identified as the gold standard of treatment, but it is noted that Mohs surgery or other forms of staged excision may be considered for certain subtypes. Topical therapy or traditional radiation may be considered as second-line therapy in cases in which surgery is not possible. However, because of a lack of evidence, the guidelines do not recommend electronic brachytherapy.

“The guidelines development process included patient advocate and community dermatologist input, and the resulting document emphasizes the importance of the doctor–patient dialogue in all aspects of melanoma management,” said board-certified dermatologist Hensin Tsao, MD, PhD, FAAD, co-chair of the guidelines work group. “Every case is unique, so physicians should work with their patients, and other specialists if necessary, to explain the available options and determine the best possible treatment plan for each patient.”

REFERENCES:

1. Swetter SM, Tsao H, Bichakjian CK, et al. Guidelines of care for the management of primary cutaneous melanoma. [published online November 1, 2018]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2018.08.055.

2. American Academy of Dermatology releases guidelines for melanoma treatment [press release]. Rosemont, IL: American Academy of Dermatology; November 1, 2018. www.aad.org/media/news-releases/melanoma-guidelines. Accessed November 1, 2018.

 

Pembrolizumab Plus Chemotherapy Approved to Treat Metastatic Squamous NSCLC

On October 30, 2018, the FDA approved1 pembrolizumab (Keytruda) in combination with carboplatin and paclitaxel or nab-paclitaxel for the first- line treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC).

The approval was based on findings from the KEYNOTE-407 trial, a randomized, double-blind, multicenter, placebo-controlled study that investigated the efficacy of the combination treatment in patients with metastatic squamous NSCLC regardless of tumor PD-L1 expression. Patients were randomized to receive pembrolizumab 200 mg and carboplatin every 3 weeks for 4 cycles, plus paclitaxel every 3 weeks for 4 cycles or nab-paclitaxel on days 1, 8, and 15 of every 3-week cycle for 4 cycles, followed by placebo every 3 weeks.

The trial found that pembrolizumab in combination with chemotherapy significantly improved overall survival and reduced the risk of death by 36% compared with chemotherapy alone (hazard ratio = 0.64 [95% CI, 0.49, 0.85]; P = .0017).

“Today’s approval expands our current lung cancer indications to include combination treatment in patients with squamous cell carcinoma, a type of lung cancer that is particularly difficult to treat,” said Roger M. Perlmutter, MD, president of Merck Research Laboratories.

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