FDA Approvals in CRC, Blood Cancer Detection Diagnostic, and Alopecia, and More

Today-

FDA approvals in colorectal cancer, a diagnostic for blood cancer detection, and alopecia, impressive findings in a phase III melanoma study, and a European approval in non—small cell lung cancer.

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

The FDA has approved panitumumab in combination with FOLFOX as a frontline treatment for patients with RAS wild-type metastatic colorectal cancer.

In addition to the frontline approval, the agency also cleared panitumumab as a monotherapy for RAS wild-type mCRC following prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.

For the determination of RAS status—specifically exons 2, 3, and 4 of KRAS and NRAS—the FDA also approved a multigene, next-generation sequencing-based companion diagnostic.

The expanded RAS indication was based on an improvement in overall survival in the prospective phase III 20100007 study and in a retrospective biomarker analysis of the phase III PRIME study. The addition of panitumumab to FOLFOX improved OS by 5.6 months for untreated patients with mCRC in the PRIME study. Additionally, panitumumab improved OS by 3.1 months versus best supportive care in the 20100007 study for patients with chemorefractory RAS wild-type mCRC.

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The FDA has also approved ClearLLab multicolor reagents T1, T2, B1, B2, and M for the detection of chronic leukemia, acute leukemia, non-Hodgkin lymphoma, multiple myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms. This approval represents the first from the agency for immunophenotyping on a flow cytometer.

The approval was based on the efficacy of the screening panel versus alternative methods for the detection of leukemias and lymphomas in 279 samples at 4 clinical sites. The findings from the ClearLLab reagents aligned with standard methods in 93.4% of the samples. Additionally, the diagnostic correctly detected cancer in 84.2% of samples.

These reagents can be used on peripheral whole blood, bone marrow, and lymph node specimens. Each of the ClearLLab reagents is specific to CD45, which is expressed on a variety of leukocyte populations.

In addition to CD45, the tests provide qualitative results for several other factors associated with hematologic malignancies. The T1 reagents illuminate CD2, CD56, CD7, and CD5. T2 is specific to CD8, CD4, and CD3. The B1 test detects Kappa, Lambda, CD19, and CD5 while B2 is specific to CD20, CD10, CD19, and CD38. The M test detects CD7, CD13, CD34, and CD33.

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The FDA has also expanded the indication for the DigniCap Cooling System to be used for alopecia reduction across all solid tumors. The device had previously been approved in 2015 solely for reducing severe hair loss in patients with breast cancer.

The initial breast cancer approval was based on an analysis of 122 women with stage I/II breast cancer who were undergoing alopecia-inducing chemotherapy. Results of the open-label, nonrandomized study showed that more than 66% of the women who used the device lost less than 50% of their hair. None of the patients in the control arm met this milestone.

The cooling cap circulates cold liquid through a silicone cap that is worn on the head during treatment with chemotherapy. The cap is connected to a unit that distributes the cooled liquid that is controlled using touchscreen prompts. A second cap made of neoprene holds the initial cap in place and prevents loss of cooling.

The near-freezing temperatures are intended to constrict the blood vessels in the scalp, making it difficult for toxic chemotherapy agents to reach and harm the hair follicles. The cold also decreases the activity of the hair roots, which slows down cell division and makes them less affected by chemotherapy.

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In melanoma, adjuvant treatment with nivolumab was found to extend recurrence-free survival versus ipilimumab in patients with advanced disease.

Data from the phase III CheckMate-238 trial have not been released, but the manufacturer of both immunotherapy agents, Bristol-Myers Squibb, reported that 3 mg/kg of nivolumab met its primary endpoint by demonstrating superior RFS compared with 10 mg/kg of ipilimumab in patients with stage IIIb/c or stage IV melanoma who are at high risk for recurrence following complete surgical resection.

In the ongoing CheckMate-238 study, 906 patients were randomized to receive either 3 mg/kg of nivolumab every 2 weeks or 10 mg/kg of ipilimumab every 3 weeks for 4 doses, then every 12 weeks for 1 year or until documented disease progression or unacceptable toxicity.

Complete findings will be presented at a future medical meeting.

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The European Union has approved the use of ceritinib as a first-line treatment for patients with ALK-positive advanced non—small cell lung cancer, making the ALK inhibitor now available for patients in all 28 EU member states plus Iceland, Lichtenstein, and Norway.

The approval is based on findings from the phase III ASCEND-4 trial, in which ceritinib was associated with a 45% reduced risk for death compared with chemotherapy. Additionally, the median progression-free survival benefit favoring ceritinib was 8.5 months.

The EU’s Committee for Medicinal Products for Human Use issued a positive opinion regarding first-line ceritinib in May. Also in May, the FDA approved the drug for use in the same patient population.

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This week, Dr. Daniel Petrylak of Yale Cancer Center discussed his appreciation for being named a 2017 Giant of Cancer Care in Genitourinary Cancer.

That’s all for today.

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