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FDA Approves Pembrolizumab For Metastatic Small Cell Lu...

(FDA.gov) June 18, 2019 - On June 17, 2019, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck) f...

Time to End PPS-Exempt Status for Certain Cancer Centers?

(MedPage Today) June 17, 2019 - The care provided at 11 specialized cancer centers granted exemption from the Medicare Prospective Payment Sys...

Roche Wins Japan Approval For Personalized Cancer Drug ...

(Reuters) June 18, 2019 - Swiss drugmaker Roche’s push into personalized cancer medicines hit a milestone on Tuesday with Japanese approval ...

AstraZeneca’s Lynparza Gets EU Nod As First-Line ...

(Reuters) June 18, 2019 - British drugmaker AstraZeneca Plc on Tuesday said its cancer medicine Lynparza was approved as a first-line maintena...

Featured Content

Naiyer Rizvi, MD, explains the role of biomarkers in lung cancer treatment planning

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center and Toni Choueiri, MD, Director of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber Cancer Institute, discuss Keytruda's approval in renal cell carcinoma (RCC).

At a recent roundtable, three hematology experts discussed treatment trends and recent clinical advances in multiple myeloma (MM). Quadruplet versus triplet drug combinations and the role of stem cell transplant and maintenance therapy were among the topics.

Bo Gamble provided insight at COA 2019 into how commercial payers from large to small are experimenting with new physician payment models in the shift from volume- to value-based reimbursement.

Industry executives at COA 2019 offered their distinct perspectives on assessing drug value, determining drug pricing and evaluating cost for oncology drugs in the current turbulent healthcare marketplace.

At COA 2019, panelists at a session were enthusiastic about how an AI tool, adapted into three practices’ clinical workflows, provided first-hand proof that artificial intelligence could deliver more value-based cancer care in the community oncology setting.

Podcasts

Keytruda RCC Approval/I-O - Toni Choueiri, MD, and Robert Figlin, MD, discuss the recent Keytruda approval in renal cell carcinoma (RCC)

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Renal Cell Carcinoma (RCC) - Rana McKay, MD, and Robert Figlin, MD, discuss clinical highlights from ASCO GU 2019

03/05/19

Colorectal Cancer (CRC) - Axel Grothey, MD, and Robert Figlin, MD, provide clinical update in CRC

03/05/19

Hepatocellular Carcinoma (HCC) - Richard Finn, MD, and Robert Figlin, MD, discuss clinical highlights from ASCO GI 2019

02/13/19

Biliary Tract and GE Junction Cancers - Tanios Bekaii-Saab, MD, FACP, and Robert Figlin, MD, discuss clinical highlig...

02/08/19

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Shirish Madhav Gadgeel, MBBS, on treating patients who have already received PD-L1 targeting agents

Lakshmi Aggarwal, MD, explains why transparency is necessary in the healthcare system

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May 2019 Edition

At COA 2019, panelists at a session were enthusiastic about how an AI tool, adapted into three practices’ clinical workflows, provided first-hand proof that artificial intelligence coul...

May 2019 Edition

Industry executives at COA 2019 offered their distinct perspectives on assessing drug value, determining drug pricing and evaluating cost for oncology drugs in the current turbulent healt...

May 2019 Edition

Bo Gamble provided insight at COA 2019 into how commercial payers from large to small are experimenting with new physician payment models in the shift from volume- to value-based reimburs...

May 2019 Edition

At a recent roundtable, three hematology experts discussed treatment trends and recent clinical advances in multiple myeloma (MM). Quadruplet versus triplet drug combinations and the rol...

Blog

ASCO Highlights for Tuesday June 4, 2019

Jun 04, 2019

As the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting comes to an end, one of today’s final sessions included follow-up data from a phase 1b s...

ASCO Late-Breakers for Monday June 3, 2019

Jun 03, 2019

Late-breaking studies featured today at this morning’s press briefing as the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting continues included...

ASCO Plenary Sessions for Sunday, June 2, 2019

Jun 02, 2019

Today, four plenary sessions dropped at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting featured results from three phase 3 trials: ENZAMET, ...

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The Oncology Business Dynamics Learning Platform addresses the need to have a high level of understanding of the non-clinical issues that are influencing the decision making process for hem/oncs today.

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Oncology Events Calendar

May 29, 2020

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Friday

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June 18 - 22, 2019

International Conference on Malignant Lymphoma (ICML)

Lugano, Switzerland

June 21 - 23, 2019

MASCC/ISOO 2019 Annual Meeting (Multinational Association of Supportive Care in Cancer & International Society of Oral Oncology)

San Francisco, CA

June 27, 2019

NCCN Policy Summit: The State of Cancer Care in America: The Impact of State Policy on Access to High-Quality Cancer Care

Washington, DC

June 29 - 30, 2019

The 7th International Conference On Advances In Hematology & Oncology (ICAHO19) - ASCO® 2019 Annual Meeting Review (Binaytara Foundation)

Seattle, WA

July 12, 2019

NCCN Policy Summit: Defining and Applying Quality in an Evolving Health Policy Landscape and the Implications for Cancer Care

Washington, DC

September 12 - 14, 2019

12th AACR Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved

San Francisco, CA

September 25 - 28, 2019

OBR Radar

Top 5 Market Moving Events

Date	Company and Product
Jun 17	Merck , Keytruda® (pembrolizumab) On June 17, 2019 the FDA approved Keytruda as monotherapy for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. This marks the first approval for Keytruda in SCLC. The accelerated approval is based on tumor response rate and durability of response from pooled data in KEYNOTE-158 (cohort G) and KEYNOTE-028 (cohort C1). The five-year survival rate for SCLC is only 6% overall, Merck said in a press release, stressing the need for significant new treatment options for the disease. Keytruda is being studied in combination with chemotherapy in the ongoing phase 3 KEYNOTE-604 study in patients with newly diagnosed extensive stage SCLC.
Jun 21	Agios Pharmaceuticals , Tibsovo® (ivosidenib) The PDUFA date is June 21, 2019 for Agios' supplemental New Drug Application (sNDA) for Tibsovo as a potential treatment for patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation who are not eligible for standard therapy. The application is under Priority Review and is being reviewed under the FDA’s Real-Time Oncology Review pilot program. The sNDA is based on data from untreated AML patients in a phase 1 dose-escalation and expansion trial of ivosidenib in patients with newly diagnosed AML ineligible for standard treatment.
Jun 30	Pfizer , PF-06439535 (proposed biosimilar to bevacizumab) In August 2018, the FDA accepted for review a BLA for PF-06439535, Pfizer's proposed biosimilar to Avastin. Pfizer said in its third quarter earnings 2018 press release on Oct. 30, 2018 that the expected Biosimilar User Fee Act (BsUFA) goal date for a decision by the FDA is second-quarter 2019. In February 2019, Pfizer announced the EC approved Zirabev (PF-06439535), a biosimilar to Avastin, for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent NSCLC, advanced and/or metastatic RCC and persistent, recurrent or metastatic carcinoma of the cervix.
Jul 06	Karyopharm Therapeutics, oral selinexor Karyopharm Therapeutics said on Mar. 14, 2019 that U.S. regulators had extended the PDUFA action date for the NDA for selinexor by three months from Apr. 6, 2019 to July 6, 2019. The NDA is currently under Priority Review by the FDA with the company seeking an accelerated approval for selinexor in combination with dexamethasone for patients with relapsed/refractory multiple myeloma (RRMM) who have received at least three prior therapies. The FDA's ODAC voted 8 to 5 on Feb. 26, 2019 that the FDA wait for results from the phase 3 BOSTON study, evaluating selinexor in patients with RRMM, before making a final decision regarding approval. Karyopharm's stock fell 40% on Feb. 22 as FDA briefing documents were released in which the agency's reviewers said that selinexor was associated with "significant toxicity" with "worse overall survival than physician's choice" (KCP-330-008 study). The FDA team also said that, "Given the limited efficacy and significant toxicity demonstrated in this population, it is unclear whether treatment with selinexor-dexamethasone provides a clinically meaningful benefit that outweighs the risks of treatment." Data from BOSTON is expected in late Q4 2019 or Q1 2020. At the FDA's request, following the ODAC meeting, the company submitted additional, existing clinical information as an amendment to the NDA, allowing the FDA to give the PDUFA extension. The oral therapy is being evaluated in several other mid- and late-phase clinical trials including the pivotal, randomized phase 3 study in RRMM in combination with Velcade® (bortezomib) and low-dose dexamethasone (BOSTON), as a potential backbone therapy in combination with approved therapies (STOMP), in diffuse large B-cell lymphoma (SADAL), and in liposarcoma (SEAL).
Aug 03	Daiichi Sankyo , pexidartinib An Oncologic Drugs Advisory Committee (ODAC) voted 12-3 in favor of the approval of Daiichi Sankyo's pexidartinib as a treatment for the symptomatic tenosynovial giant cell tumor (TGCT) in a morning session on May 14, 2019. TGCT is a rare, non-cancerous tumor associated with severe morbidity or functional limitations, which is not amenable to improvement with surgery. The panel however supported strategies that the company proposed to mitigate the risk associated with pexidartinib, including educating healthcare providers about monitoring changes and modifying drug dosage as prescribed. The company said that pexidartinib would be distributed only through specialty pharmacies and both wholesalers and pharmacies would have to complete a certification process in order to dispense the therapy. If approved by the FDA, pexidartinib would be the first and only approved therapy for TGCT. ASCO selected pexidartinib as one of five significant advancements in rare disease treatment in its latest "Clinical Cancer Advances" report. The PDUFA action date of the therapy is Aug. 3, 2019.