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U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as the First New Medication in Nearly 20 Years for Certain Patients with Previously Treated Small Cell Lung Cancer

(BMS) Aug 17, 2018 - Bristol-Myers Squibb Company today announced that Opdivo (nivolumab) received approval from the U.S. Food and Drug Administration (FDA) as the first and only Immuno-Oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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FDA Approves Lenvatinib For Unresectable Hepatocellular Carcinoma

(FDA.gov) Aug 16, 2018 - On August 16, 2018, the Food and Drug Administration approved lenvatinib capsules (Lenvima, Eisai Inc.) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on an international, multicenter, randomized, open-label, non-inferiority trial (REFLECT; NCT01761266) conducted in 954 patients with previously untreated, metastatic or unresectable HCC. Patients were randomized (1:1) to receive lenvatinib (12 mg orally once daily for patients with a baseline body weight of ≥60 kg and 8 mg orally once daily for patients with a baseline body weight of <60 kg) or sorafenib (400 mg orally twice daily). Treatment continued until radiological disease progression or unacceptable toxicity.

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FDA Updates Prescribing Information for Keytruda and Tecentriq

(ASCO in Action) Aug 16, 2018 - On August 16, 2018, the Food and Drug Administration updated the prescribing information for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. FDA approved two different companion diagnostic tests, one for use with Keytruda and one for use with Tecentriq, as described below. On August 16, 2018, the FDA approved the Dako PD-L1 IHC 22C3 PharmDx Assay (Dako North America, Inc.) as a companion diagnostic to select patients with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible for treatment with Keytruda. The 22C3 assay determines PD-L1 expression by using a combined positive score (CPS) assessing PD-L1 staining in tumor and immune cells. The updated indication for Keytruda is:

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Oncology Clinical News

Californians Living Longer With Cancer — Some Longer Than Others

(California Healthline) Aug 17, 2018 - Californians are living longer with most types of cancer, due to earlier detection and more effective treatments, according to new research. But racial, ethnic and socioeconomic disparities persist, the report found. The report also found improved survival rates for patients with all but five types of cancer.

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Cancer Risk With Diabetes Is Higher For Women Than Men

(Reuters Health) Aug 15, 2018 - People with diabetes are more likely to develop certain cancers than those without the condition, and a new analysis suggests that the increased risk is greater for women than for men.

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An Intelligent Knife Can Tell Ovarian Cancer And Healthy Tissue Apart. Could It Make Surgery Smarter?

(Cancer Research UK/Science blog) Aug 17, 2018 - Surgery is a major part of ovarian cancer treatment, but it can be a blunt tool.

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Newly Discovered Class Of Molecules May Boost Cancer Vaccine Development

(Broad Institute) Aug 16, 2018 - Researchers predicted these cancer-specific peptides, dubbed "retained intron" neoantigens, by computationally sifting through melanoma patients' tumor RNA.

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Oncology Business and Policy News

Japan's Eisai Sets Price Tag Of About $16,000 On Liver Cancer Drug

(Reuters) Aug 16, 2018 - Japan's Eisai Co Ltd said on Thursday it would price its cancer drug Lenvima at about $16,000 for a month's supply before discounts, after the U.S. Food and Drug Administration approved its use in patients with a common form of liver cancer. The drug was approved as the first therapy in over a decade in the United States to treat previously untreated patients with an advanced or intermediate stage of unresectable hepatocellular carcinoma (HCC). “The price at which the recommended starting dose of Lenvima for unresectable HCC will be sold to wholesalers, excluding discounts, is $15,970 for a 30-day supply,” Eisai told Reuters.

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How to Pay For CAR-T: A Conversation With Health Policy Expert Peter Bach

(STAT Plus) Aug 17, 2018 - How much should drugs cost? To Dr. Peter Bach, the answer is almost always cheaper.

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Medicaid Work Requirements Could Reduce Vulnerable Patients’ Access to Cancer Care

(ASCO) Aug 16, 2018 - In a new position statement released today, ASCO also recommends that federal and state policymakers take specific steps to ensure that new Medicaid requirements will not harm patients with cancer.

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Mateon Therapeutics Receives Notice of Partial Clinical Hold for OX1222 Study

(Morningstar) Aug 17, 2018 - Mateon Therapeutics, Inc., a biopharmaceutical company developing investigational drugs for the treatment of orphan oncology indications, today announced that the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on Study OX1222 during a telephone conversation held with the Company on August 16, 2018.

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Tolero Pharmaceuticals Announces Clinical Research Collaboration with AbbVie for Acute Myeloid Leukemia Trial

(The Business Journals) Aug 17, 2018 - Tolero Pharmaceuticals, Inc. has entered into a clinical research collaboration with AbbVie, a research-based global biopharmaceutical company, exploring the potential of combination therapy with AbbVie's venetoclax and Tolero's investigational agent, alvocidib, for the treatment of relapsed/refractory acute myeloid leukemia (AML).

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NICE Sticks With ‘No’ For Use Of Perjeta After Breast Cancer Surgery

(PharmaTimes [UK]) Aug 17, 2018 - NICE is sticking with its position that Roche’s Perjeta is not cost-effective enough to be used by the NHS post surgery to prevent breast cancer recurrence.

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The Agonizingly Slow Progress Against The Cancer That Killed Aretha Franklin

(Forbes) Aug 16, 2018 - Say a big prayer for the Queen of Soul – but a little one, too, for the scientists who are making slow progress against the disease that killed her.

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Broader Healthcare and Pharma News

FDA Approves Teva’s Generic EpiPen After Yearslong Delay

(CNBC) Aug 16, 2018 - U.S. regulators cleared the first generic competitor to Mylan's EpiPen, after a yearslong delay that many said contributed to the emergency allergy drug's rapid rise in price.

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EpiPen Shortage Raises Alarm For Parents As Kids Head Back To School

(Washington Post) Aug 16, 2018 - The scarcity of the emergency medicines, which prevent people with serious allergies from going into anaphylactic shock, means families will have to go from pharmacy to pharmacy hoping to get lucky, or rely on expired doses.

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Senators Challenge Azar On Assertion That Middlemen Are Preventing Drugmakers From Lowering Prices

(KHN Morning Briefing) Aug 17, 2018 - Sen. Elizabeth Warren (D-Mass.) and Sen. Tina Smith (D-Minn.) are seeking a response from the secretary of Health and Human Services about his answers in recent congressional testimony.

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