Oncology

On Sunday, December 10, at the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Noah Federman, MD, will present research from a phase 2 study on the use of subcutaneous tbo-filgrastim (Granix) in pediatric patients with solid tumors who are undergoing chemotherapy.

On Saturday, December 9, at the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Scott Huntington, MD, MPH, will present his research team’s findings that the receipt of lymphoma care in the community-based setting is associated with guideline-discordant use of rituximab.

Russian biosimilar developer Biocad has announced that it will begin manufacturing its rituximab and bevacizumab biosimilars in Morocco. The 2 drugs, manufactured in partnership with Sothema Labs, will be sold in numerous markets in North Africa, including Morocco, Senegal, Gabon, and Cote d’Ivoire.

Yesterday, community oncology leaders flooded the Hill to meet with Congress and the administration to warn them of the impact the Medicare sequester’s increased cuts and extension will have on cancer care nationwide.

The FDA has approved Mylan–Biocon’s trastuzumab biosimilar, MYL-1401O, referenced on Roche’s Herceptin. The drug will be marketed in the United States as Ogivri.

Drug maker Biocon has launched a biosimilar bevacizumab (referenced on Avastin) in India.

Trastuzumab has been used to manage both early and metastatic HER2-postive breast cancer and has significantly improved the survival of these patients and become the standard of care, according to Arlene Chan, MB BS, FRACP, MMed, writing in Chinese Clinical Oncology.

A new study, the phase 3 IMpower150, demonstrated Genentech’s atezolizumab (Tecentriq) and innovator bevacizumab (Avastin) plus paclitaxel and carboplatin chemotherapy significantly reduced the risk of disease worsening or death in the treatment of advanced lung cancer.

A retrospective Chinese study of 59 people with brain edema related to metastatic cancer finds that bevacizumab (Avastin) is an effective and relatively safe treatment for brain edema, with a low risk for cerebral hemorrhage.

Australian researchers Kellie A. Mouchemore, PhD, and colleagues urge caution in the use of granulocyte colony stimulating factor (G-CSF) in neutrophil recovery following chemotherapy for breast cancer because there is increasing evidence that G-CSF can promote metastasis.

Drug makers Amgen and Allergan announced on Friday that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on ABP 215, the companies’ bevacizumab biosimilar. CHMP recommended the biosimilar for approval for the treatment of multiple cancer indications.

The Center for Biosimilars® recaps the top 5 stories in biosimilars news for the week of October 30.

The FDA has accepted Genentech’s supplemental Biologics License Application (sBLA) for its innovator bevacizumab (Avastin) in combination with carboplatin and paclitaxel chemotherapy, followed by Avastin alone, for the front-line treatment of women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

More than 90% of Americans believe that the cost burden of cancer is too high, according to a large, nationally representative survey conducted for the American Society of Clinical Oncology (ASCO).

A recent study found that injectable anticancer drugs steadily increase in price, even after competition enters the market.

Russian biosimilar developer Biocad has won a legal battle that will allow it to move forward with its rituximab biosimilar.

A paper by Matti Aapro, MD, recently published in Supportive Cancer Care, outlined, for the first time, consensus recommendations on using pegfilgrastim in particular patients and therapeutic scenarios.

Data from 5 studies presented at the European Society for Medical Oncology (ESMO) 2017 meeting highlighted the progress of biosimilar trastuzumab candidates.

Switching patients from originator biologics to biosimilars is associated with the potential for a “nocebo” effect, a phenomenon that occurs when a patient’s negative expectation causes a treatment to have a more negative effect than it otherwise would—essentially, the opposite of the placebo effect.

A study newly published in the Journal of Clinical Oncology found that, regardless of competition or additional approved indications, injectable anticancer drugs are subject to steady increases in price after launch.

In recent paper published in Rheumatology, authors Till Uhlig, MD, and Guro L. Goll, PhD explore some of the remaining barriers to the adoption of biosimilar therapies in Europe. Physician attitudes, patient concerns, and prescribing restrictions on biologic therapies are all identified in the paper as having a role curbing uptake of biosimilars.

The FDA has issued a Complete Response Letter for Mylan and Biocon’s pegfilgrastim biosimilar, MYL-1401H, referenced on Neulasta.

Brandon Shank, PharmD, MPH, BCOP, Clinical Pharmacy Specialist, discusses the need for pharmacy schools to adapt their curriculum to address biosimilar treatments.

A European study published this week finds that, at a minimum of 3.3 years after market entry, there was no conclusive evidence that many oncology drugs approved by the European Medicines Agency between 2009 and 2013 either extended or improved life in most oncology indications.

Cinfa Biotech has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for biosimilar pegfilgrastim.

Indication-based pricing is a method used to reimburse drug makers according to a drug’s indication-specific value when the drug has multiple indications. A number of healthcare payers have already implemented or are planning to implement IBP, including Express Scripts, the largest US pharmacy benefit manager.

The number of people who had annual prescription medication costs of $50,000 or more in 2016 was 35% higher than it was in 2014, according to pharmacy benefit manager Express Scripts.

Complete phase 3 data show that a biosimilar almost beat reference trastuzumab (Herceptin) for the primary endpoint of pathologic complete response in patients with HER2-positive early breast cancer.

If Roche is successful in securing FDA approval, use of pertuzumab together with trastuzumab (also developed by Genentech's parent company, Roche) could help the drug maker hold on to some of its oncology market dominance in the face of growing competition from anticancer biosimilars.

Medicines for Europe says that the sustainability of healthcare budgets in European nations has been “intensely pressured” in recent years by factors including an aging population and the introduction of high-cost drugs, and that governments aiming to address those challenges have resorted to austerity measures that have “driven the prices of some off-patent medicines to unsustainably low levels."