The Lynx Group

Web Exclusives

Web Exclusives — May 4, 2020
On April 29, 2020, the FDA accelerated the approval of the oral poly ADP-ribose polymerase (PARP) inhibitor niraparib (Zejula; GlaxoSmithKline) as the first and only drug approved for first-line maintenance therapy of all patients with advanced ovarian cancer—including epithelial ovarian, fallopian tube, or primary peritoneal cancer—who have had a complete or partial response to first-line platinum-based chemotherapy.
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Web Exclusives — May 4, 2020
On April 28, 2020, the FDA accelerated the approval of a new dosing regimen—400 mg every 6 weeks—for pembrolizumab (Keytruda; Merck) for all the 15 indications currently approved by the FDA for adults using this PD-1 inhibitor. The new dosing regimen is a new option in addition to the current dosing regimen of 200 mg every 3 weeks. This is great news for patients, as well as for oncology providers.
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Web Exclusives — April 28, 2020

In the Association for Value-Based Cancer Care (AVBCC) webcast, titled Wholesale Supply Channels: COVID-19 Impact on Cancer Care and Road to Recovery, a panel of healthcare experts discussed issues related to wholesale supply channels for the distribution of drugs and medical/surgical supplies to community oncology care providers.

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Web Exclusives — March 19, 2020
The Centers for Medicare & Medicaid Services (CMS) has broadened access to Medicare telehealth services so that beneficiaries can receive a wider range of services from their physicians without having to travel to a healthcare facility. Clinicians can bill immediately for services starting March 6, 2020.
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Web Exclusives — February 4, 2020
On January 29, 2020, Eli Lilly announced that the FDA granted priority review to their New Drug Application for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion-positive non–small-cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer.
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Web Exclusives — January 28, 2020
On January 23, 2020, the FDA granted accelerated approval to tazemetostat (Tazverik; Epizyme), a methyltransferase inhibitor, for the treatment of metastatic or locally advanced epithelioid sarcoma in adults and pediatric patients aged ≥16 years who are not eligible for complete resection.
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Web Exclusives — January 21, 2020
On January 8, 2020, the American Cancer Society published details of their annual cancer statistics report, including the most recent data on population‐based findings for cancer incidence through 2016 and for mortality through 2017 (CA Cancer J Clin. 2020;70:7-30). The report revealed encouraging news as well as some sobering trends.
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Web Exclusives — January 13, 2020
The FDA approval of avapritinib marks the first time a drug has been approved specifically for patients with GIST harboring PDGFRA exon 18 mutations, which are involved in approximately 10% of GIST cases.
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Web Exclusives — January 7, 2020
The FDA has confirmed another strong year regarding the approval of innovative new drugs and biosimilars, including several agents used in the treatment of patients with cancer.
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Web Exclusives — December 16, 2019
On December 12, 2019, the FDA issued draft guidance to implement amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act that will facilitate early assessment of studies of molecularly targeted oncology drugs that may be effective in the treatment of pediatric cancers.
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