January 4, 2018 : Episode 1

FDA Approvals in Melanoma and Breast Cancer, Priority Reviews in Prostate Cancer and More



FDA approvals in melanoma and breast cancer, priority review designations in prostate cancer, melanoma, Hodgkin lymphoma, and neuroendocrine tumors, and breakthrough therapy designations in breast cancer and renal cell carcinoma.

Welcome to OncLive News Network! I’m Gina Columbus.

In melanoma, the FDA has approved nivolumab as an adjuvant treatment for patients with completely resected disease with lymph node involvement or metastatic disease. The decision was based on findings from the phase III CheckMate-238 trial.

This approval represents the first granted to an adjuvant melanoma therapy based on comparison to an active control arm.

In the randomized study, the recurrence-free survival rate at 18 months with nivolumab was 66.4% compared with 52.7% for ipilimumab in patients with stage IIIB/C or IV melanoma. There was a 35% reduction in the risk of recurrence or death with the PD-1 inhibitor versus the CTLA-4 inhibitor.


The FDA has approved pertuzumab in combination with trastuzumab and chemotherapy as an adjuvant treatment for patients with HER2-positive early breast cancer at high risk for recurrence, based on results from the APHINITY trial.

In the phase III study, the adjuvant pertuzumab regimen demonstrated a 3-year invasive disease-free survival rate of 94.1% versus 93.2% for those who received trastuzumab plus chemotherapy and placebo. This represented an 18% reduction in the risk of developing invasive disease or death. The 4-year iDFS rates were 92.3% versus 90.6%, respectively.

The FDA’s decision also transitioned an accelerated approval granted to pertuzumab in September 2013 to a full regulatory approval for neoadjuvant use of the agent in combination with trastuzumab and docetaxel for patients with HER2-positive, locally advanced, inflammatory, or early breast cancer. Those receiving the pertuzumab regimen in the neoadjuvant space can continue both HER2-blocking agents for 12 months following surgery.


The FDA has approved a novel breast-specific stereotactic body radiotherapy device known as GammaPod as a treatment for patients with early breast cancer.

In the small 17-patient clinical trial, GammaPod was effectively used to deliver a single “boost” radiation dose of 8 Gy directly to the tumor, while only eliciting grade 1 adverse events. The system uses a vacuum-assisted breast cup guided by a CT simulator with 1 mm slice thickness to immobilize the breast, which ensures the accurate delivery of radiation to the tumor.

The pivotal trial enrolled women aged 60 and older with stage 1 or 2 invasive breast cancer following breast conserving surgery with planned tangential radiation therapy.


In prostate cancer, the FDA has granted a priority review to a new drug application for apalutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer.

The NDA is based on data from the phase III SPARTAN trial, which evaluated the safety and efficacy of apalutamide versus placebo in patients with a rapidly rising prostate specific antigen level despite receiving continuous androgen deprivation therapy. The primary endpoint of the study is metastasis-free survival.

In a press release, Janssen, the manufacturer of apalutamide, stated that results from the trial will be presented at the Genitourinary Cancers Symposium in February. Under the Prescription Drug User Fee Act, the FDA is scheduled to makes its decision on the application by April 2018.


The FDA has granted a priority review to a supplemental new drug application for the use of dabrafenib combined with trametinib as an adjuvant treatment for patients with BRAF V600E or V600K positive stage III melanoma following complete resection.

The application is based on findings from the phase III COMBI-AD study, in which adjuvant treatment with the combination reduced the risk of relapse or death by 53% versus placebo for patients with BRAF-mutant stage III melanoma. After a median follow-up of 2.8 years, the 3-year relapse-free survival rate with dabrafenib and trametinib was 58% compared with 39% for placebo.

The priority review follows an FDA breakthrough therapy designation granted to the combination in October 2017 for use in this setting.


In Hodgkin lymphoma, the FDA granted a priority review to a supplemental biologics license application for brentuximab vedotin in combination with Adriamycin, vinblastine, and dacarbazine as a frontline therapy for advanced classical Hodgkin lymphoma.

The application is based on results from the phase III ECHELON-1 trial, which demonstrated superior progression-free survival with brentuximab vedotin plus AVD compared with standard ABVD, which is AVD plus bleomycin.

In the study, the brentuximab vedotin regimen reduced the risk of progression, death, or initiation of new therapy by 23% versus ABVD. The 2-year modified PFS rate was 82.1% with brentuximab vedotin compared with 77.25% for standard chemotherapy.

Under the Prescription Drug User Fee Act, the FDA is scheduled to make its final decision on the sBLA by May 1, 2018.


The FDA has granted a priority review designation to a novel version of the radiopharmaceutical iobenguane I-131 for patients with malignant or recurrent pheochromocytoma or paraganglioma.

The new drug application for iobenguane I-131 was based on findings from a phase IIb clinical trial that was conducted under the FDA’s special protocol assessment. In the study, the radiopharmaceutical elicited a more than 50% reduction in antihypertensive medication use for more than 6 months for 25% of patients with PPGL. In those receiving at least 2 therapeutic doses, this was achieved for 32% of patients.

Under the Prescription Drug User Fee Act, the FDA is scheduled to make its decision on the NDA by April 30, 2018.


In breast cancer, the FDA has granted ribociclib a breakthrough therapy designation for use in combination with tamoxifen or an aromatase inhibitor as frontline treatment for pre- or perimenopausal women with hormone receptor—positive, HER2-negative advanced or metastatic breast cancer.

The CDK4/6 inhibitor received the designation based on the phase III MONALEESA-7 trial. In the study, the median progression-free survival was 23.8 months for women treated with ribociclib in combination with either tamoxifen or a nonsteroidal AI and goserelin, compared with 13.0 months for those who received the standard endocrine therapy plus placebo and goserelin.

The phase III findings demonstrate for the first time that a CDK4/6 inhibitor is effective in younger patients who currently have few treatment options. The breakthrough designation will expedite the development and review of ribociclib in this setting.


The FDA has granted the PD-L1 inhibitor avelumab a breakthrough therapy designation for use in combination with the VEGF inhibitor axitinib in treatment-naïve patients with advanced renal cell carcinoma.

The designation is based on findings from the phase Ib JAVELIN Renal 100 trial. In the study, frontline avelumab/axitinib induced a response rate of 58.2% in patients with advanced RCC. The complete response rate was 5.5%, the partial response rate was 52.7%, and the disease control rate was 78.2%.

An additional patient still receiving therapy had an unconfirmed response. Eleven patients had stable disease, 10 had progressive disease, and 2 were not evaluable.


This week, we sat down with Dr Nathan Fowler of The University of Texas MD Anderson Cancer Center to discuss subcutaneous rituximab as a new approach to treating patients with follicular lymphoma.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.

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