Merkel Cell Carcinoma Drug Approval Tops Week in Cancer News


Top news of the week in oncology and cancer drug development.

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FDA Approves Niraparib for Ovarian Cancer

The FDA has approved the PARP inhibitor niraparib (Zejula) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. The approval is based on the phase III NOVA trial, in which niraparib reduced the risk of progression or death by 74% compared with placebo for patients with germline BRCA-positive platinum-sensitive, recurrent ovarian cancer.

In the study, the median progression-free survival was 21 months with maintenance niraparib compared with 5.5 months for placebo in patients with germline BRCA mutations. The results were consistent across subgroups of patients, including those without BRCA mutations. Tesaro, the manufacturer of niraparib, stated that it anticipates that niraparib will be officially launched in the United States in late April.

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FDA Approves Avelumab for Merkel Cell Carcinoma

The FDA has granted an accelerated approval to the PD-L1 inhibitor avelumab (Bavencio) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy. The approval is based on data from the phase II JAVELIN Merkel 200 study, in which the objective response rate with avelumab was 33%, which included an 11.4% complete response rate and a 21.6% partial response rate.

The duration of response (DOR) was at least 6 months in 86% of patients, with 45% of patients having a DOR of 12 months or more. Additionally, the median progression-free survival (PFS) with avelumab was 2.7 months, and the 6-month PFS rate was 40%. The median overall survival (OS) was 11.3 months and the 6-month OS rate was 69%. Avelumab is the first treatment approved by the FDA for metastatic Merkel cell carcinoma. Its accelerated approval is contingent upon the results of confirmatory trials. Moreover, this is the first FDA approval for avelumab, which has also been granted a priority review for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed after platinum-based therapy.

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FDA Grants Maintenance Olaparib Priority Review for Ovarian Cancer

The FDA has granted a priority review to a new drug application (NDA) for olaparib (Lynparza) as a maintenance therapy in relapsed patients with platinum-sensitive ovarian cancer. The NDA is based on data from the phase III SOLO2 trial, in which maintenance olaparib showed a 70% reduction in the risk of progression or death versus placebo for patients with platinum-sensitive, relapsed, BRCA-mutant ovarian cancer. Patients randomized to olaparib had a median investigator-assessed progression-free survival (PFS) of 19.1 months compared with 5.5 months in the placebo arm.

A prespecified analysis of PFS by a blinded central review committee showed a median PFS of 30.2 months for the olaparib group versus 5.5 months for placebo, leading to a 75% reduction in the hazard for progression or death. The indication for maintenance olaparib would be for an investigational tablet formulation of the PARP inhibitor that patients would receive at 300 mg twice daily. Olaparib is currently FDA approved as a capsule formulation at 400 mg twice daily for the treatment of women with BRCA-positive advanced ovarian cancer following treatment with 3 or more prior lines of chemotherapy. Under the Prescription Drug User Fee Act, the FDA will make a final approval decision on the maintenance application by the third quarter of 2017.

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Pembrolizumab, Nivolumab Approach New Approvals in Europe

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended EU approval of pembrolizumab (Keytruda) and nivolumab (Opdivo) for new indications. The pembrolizumab indication is for adult patients with relapsed or refractory classical Hodgkin lymphoma who progressed following autologous stem cell transplant and brentuximab vedotin, or who are transplant-ineligible and have failed brentuximab vedotin.

The recommendation is based on results from the phase II KEYNOTE-087 and phase Ib KEYNOTE-013 trials. In KEYNOTE-087, the overall response rate (ORR) with pembrolizumab was 69% at a median 9.4-month follow-up. The ORR included complete responses in 22% of patients and partial responses in 47% of patients. The median duration of response was 11.1 months among the 145 responding patients.

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The nivolumab recommendation is for the treatment of patients with squamous cell cancer of the head and neck following progression on platinum-based therapy. This opinion is based on the CheckMate-141 study, in which the median overall survival with nivolumab was 7.5 months versus 5.1 months with investigator’s choice. The ORR was 13.3% versus 5.8%, respectively.

The European Commission will now review the 2 recommendations and a final approval decision for use in the EU is expected in about 2 months.

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ASCO Highlights Challenges, Hope in State of Cancer Care Report

In its annual State of Cancer Care in America report, the American Society of Clinical Oncology discussed how the Affordable Care Act has improved access to cancer care for millions of Americans, and many new drugs and new indications for existing cancer drugs were approved in 2016. However, the report emphasized that there are critical remaining challenges in improving cancer care, including information barriers, disparities in the availability of rural care, and stressors on physicians and oncology practices.

One of the chief hurdles also looming is providing ongoing care for the rising numbers of Americans who are diagnosed with cancer and who are surviving their cancer, thanks to improved therapies. ASCO said the number of cancer survivors is expected to grow by one-third, from 15.5 million in 2016 to 20.3 million by 2026.

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Osimertinib Approved in China for EGFR T790M+ NSCLC

The China Food and Drug Administration (CFDA) has approved osimertinib for the treatment of patients with locally-advanced or metastatic EGFR T790M-positive non—small cell lung cancer (NSCLC) with progression following treatment with an EGFR tyrosine kinase inhibitor. Osimertinib was approved under the CFDA’s accelerated Priority Review Pathway. To receive the treatment, patients must have their EGFR T790M mutation status confirmed through a validated test.

The FDA approved osimertinib in this setting in November 2015 based on data from 411 patients in 2 single-arm studies. In the first study, labeled AURA, the objective response rate (ORR) with osimertinib was 61% for those with EGFR T790M-mutant NSCL­­­C. In the second trial, known as AURA2, the ORR was 57%. More recently, data from the phase III AURA3 trial showed that osimertinib reduced the risk of disease progression by 70% compared with a chemotherapy doublet in patients with EGFR T790M-mutant NSCLC who progressed after first-line targeted therapy.

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Congress Continues to Debate How to Repeal and Replace the Affordable Care Act

The US House of Representatives delayed its expected March 23rd vote on the American Health Care Act (AHCA), the replacement bill for the Affordable Care Act (ACA). The Republican leadership chose to pull the legislation.

The proposed replacement legislation would have kept some provisions of the ACA, but were are also some significant differences. Among the holdovers are the policy on preexisting conditions and the prohibitions on annual and lifetime limits. These clauses are considered especially important for patients with cancer. Although healthcare reform appeared to have stalled in the aftermath of the vote delay, President Trump and Congressional Republicans have been engaged in discussions in an attempt to revive the process.

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