Value-Based Cancer Care Issues

December 2018, Vol 9, No 4

Targeted Therapy Has Significant Activity as Second-Line Treatment of Cholangiocarcinoma with FGFR Mutations

Wayne Kuznar

Emerging Therapies

Munich, Germany—Treatment options are few for patients with cholangiocarcinoma whose disease progresses while receiving first-line treatment with gemcitabine (Gemzar) and cisplatin (Platinol), with no established second-line regimen. The median overall survival (OS) is 7.2 months and the median progression-free survival (PFS) is 3.2 months in the second-line setting. [ Read More ]

First-Line Olaparib a New Standard in Women with Newly Diagnosed, BRCA-Positive Advanced Ovarian Cancer?

Phoebe Starr

Ovarian Cancer

Munich, Germany—Long-term therapy with olaparib (Lynparza), a poly (ADP ribose) polymerase (PARP) inhibitor, in women with newly diagnosed advanced ovarian cancer and a BRCA1 or BRCA2 mutation led to a significant, unprecedented improvement in progression-free survival (PFS), reducing the risk for disease progression or death by 70% compared with placebo, according to results of the phase 3 SOLO-1 clinical trial. [ Read More ]

CAR T-Cell Therapy: Can We Afford the Cure?

Meg Barbor, MPH

Value-Based Care

Chicago, IL—So far, 2 chimeric antigen receptor (CAR) T-cell therapies have been approved by the FDA for some types of relapsed or refractory lymphoma and leukemia. Although CAR T-cell therapy has shown promise in many ­patients who have run out of standard treatment options, it is incredibly ­resource-intense: the complexities of its administration ­require an interdisciplinary approach for success, the side effects can be severe, and its high cost can reach upward of $1 million per course of treatment. [ Read More ]

Lumoxiti a New Treatment Approved for Patients with Hairy-Cell Leukemia

FDA Approvals, News & Updates

On September 13, 2018, the FDA approved moxetumomab pasudotox-­tdfk (Lumoxiti; AstraZeneca), an intravenous CD22-directed cytotoxin, for adults with relapsed or refractory hairy-cell leukemia (HCL) who received ≥2 systemic therapies, including treatment with a purine nucleoside analog. The FDA used its fast track and priority review for this approval, and it granted moxetumomab pasudotox-tdfk an orphan drug designation for this indication. [ Read More ]

Vizimpro a New First-Line Targeted Therapy for Metastatic NSCLC with EGFR Mutations

FDA Approvals, News & Updates

On September 27, 2018, the FDA approved the targeted therapy dacomitinib (Vizimpro; Pfizer), an oral kinase inhibitor, for the first-line treatment of patients with meta­static non–small-cell lung cancer (NSCLC) associated with EGFR exon 19 deletion or exon 21 L858R substitution mutations, as identified by an FDA-approved test. The FDA approved dacomitinib using its priority review process and granted it an orphan drug designation. [ Read More ]

Lorbrena New Treatment Approved for Patients with Metastatic NSCLC and ALK Mutation

FDA Approvals, News & Updates

On November 2, 2018, the FDA accelerated the approval of lorlatinib (Lorbrena; Pfizer) as second- or third-line treatment for patients with metastatic non–small-cell lung cancer (NSCLC) and ALK mutation whose disease progressed during crizotinib (Xalkori) treatment and at least 1 more ALK inhibitor or during alectinib (Alecensa) or ceritinib (Zykadia) therapy as the first ALK inhibitor therapy. [ Read More ]

Daurismo New Treatment Approved for Older Adults with Acute Myeloid Leukemia

FDA Approvals, News & Updates

On November 21, 2018, the FDA approved glasdegib (Daurismo; Pfizer), an oral Hedgehog inhibitor, in combination with low-dose cytarabine (LDAC), for patients with newly diagnosed acute myeloid leukemia (AML) who are aged ≥75 years or who have comorbidities that preclude use of intensive induction chemotherapy. The FDA approved glasdegib using its priority review and granted it an orphan drug designation. [ Read More ]

Vitrakvi Second Drug Approved Based on a Genetic Biomarker, Not a Tumor Type

FDA Approvals, News & Updates

On November 26, 2018, the FDA accelerated the approval of larotrectinib (Vitrakvi; Loxo Oncology/Bayer) for the treatment of patients whose cancers have a specific genetic biomarker. This is the second drug to receive FDA approval based on a biomarker rather than a specific tumor type or site. The first drug to receive this type of approval was pembrolizumab (Keytruda), in 2017. [ Read More ]

FDA Approves Expanded Use of HPV Vaccine Gardasil 9

FDA Approvals, News & Updates

On October 5, 2018, the FDA approved the expanded use of the human papillomavirus (HPV) vaccine Gardasil 9 (9-valent vaccine, recombinant; Merck) to include men and women between the ages of 27 and 45 years. The FDA initially approved Gardasil 9 in 2006 for younger people (male and female) aged 9 years to 26 years. This HPV vaccine can prevent some types of cancers, including genital and oral cancer, as well as other diseases caused by 9 variants of HPV infection. [ Read More ]

Adcetris First FDA-Approved Drug for CD30-Expressing Peripheral T-Cell Lymphomas

FDA Approvals, News & Updates

On November 16, 2018, the FDA approved brentuximab vedotin (Adcetris; Seattle Genetics), in combination with chemotherapy, for patients with untreated systemic ­anaplastic large-cell lymphoma (sALCL) or with other CD30-­expressing peripheral T-cell lymphomas (PTCLs), including angioim­munoblastic T-cell lymphoma and PTCL not otherwise specified. This is the first FDA-approved drug for newly diagnosed PTCL, including sALCL. Brentuximab vedotin was previously approved by the FDA for classical Hodg­kin lymphoma. [ Read More ]

Alpelisib First Drug to Improve Outcomes in Advanced Breast Cancer with PIK3CA Mutation

Phoebe Starr

Breast Cancer, Emerging Therapies

Munich, Germany—Recent results with the investigational targeted therapy alpelisib, a PI3K inhibitor, showed impressive clinical benefits. Adding alpelisib to fulvestrant (Faslodex) extended progression-free survival (PFS) compared with endocrine therapy alone in patients with hormone receptor (HR)–positive, HER2-negative advanced breast cancer characterized by a PIK3CA mutation, according to the results of the SOLAR-1 trial presented at the ESMO 2018 Congress. [ Read More ]

Practice-Changing Results: Adding Immunotherapy to Chemotherapy Extends Survival in Metastatic Triple-Negative Breast Cancer

Phoebe Starr

Breast Cancer

Munich, Germany—Triple-negative breast cancer is considered one of the most difficult to treat breast cancers, with few treatment options, but finally a breakthrough study shows progress by extending patient survival. Results of the phase 3 ­IMpassion130 clinical trial show that using the checkpoint inhibitor atezolizumab (Tecentriq), a PD-L1 inhibitor, with nab-paclitaxel (Abrax­ane) chemotherapy significantly extended survival in patients with advanced or metastatic triple-negative breast cancer. [ Read More ]

Do No Financial Harm: How to Improve Cost Transparency in Cancer Care

Chase Doyle

Value-Based Care

San Diego, CA—We’ve heard the figures before: the price of cancer drugs has risen by orders of magnitude per month over the past decades, deductibles have tripled in the past 6 years, and employer contribution to premiums has increased by nearly 300% over the past 15 years. In addition to cancer treatment becoming more expensive, insurance design and drug formularies have changed, resulting in a greater financial burden for patients. [ Read More ]

Nivolumab-Ipilimumab Combination Highly Active in Metastatic MSI-H or dMMR Colorectal Cancer

Wayne Kuznar


Munich, Germany—The combination of immunotherapy with nivolumab (Opdivo) and ipilimumab (Yervoy) may soon represent a new first-line treatment option in patients with early-stage metastatic colorectal cancer (CRC) associated with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) tumors. Two studies presented at the ESMO 2018 Congress demonstrated the efficacy of this combination in this patient population. [ Read More ]