Industry News

FDA Expands Approval of HPV Vaccine to People Aged 27 to 45
On October 5, the U.S. Food and Drug Administration expanded the approved use of Gardasil 9 (Human Papillomavirus [HPV] 9-valent Vaccine, Recombinant, Merck & Co.) to include individuals aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by nine types of HPV. Gardasil 9 was previously approved for individuals aged 9 through 26 years.

Read the full FDA press release here.

Posted 10/8/2018

FDA Approves Dacomitinib for Metastatic NSCLC
On September 27, the Food and Drug Administration approved dacomitinib tablets (Vizimpro, Pfizer Inc.) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

Read the full FDA press release here.

Posted 9/28/18

FDA Approves Ibrutinib Plus Rituximab for Rare Blood Cancer
On August 27, AbbVie announced that the FDA has approved ibrutinib (Imbruvica) (Pharmacyclics, LLC) plus rituximab for the treatment of adult patients with Waldenström's macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma (NHL). This approval represents the first and only chemotherapy-free combination treatment specifically indicated for the disease.

Read the full AbbVie corporate press release here.

Posted 8/27/2018

FDA Approves Pembrolizumab + Chemotherapy for NSqNSCLC
On August 17, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations.

Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study. This approval represents fulfillment of a postmarketing commitment demonstrating the clinical benefit of this product.

Read the full FDA announcement here.

Posted 8/20/2018

FDA Approves Filgrastim Biosimilar for AML
On July 20, the Food and Drug Administration (FDA) approved filgrastim-aafi (Nivestym, Pfizer Inc.) for the treatment of chemotherapy-induced febrile neutropenia, acute myeloid leukemia (AML), patients with cancer receiving bone marrow transplant, peripheral blood progenitor cell collection and engraftment, and severe chronic neutropenia. This is the second approved biosimilar for filgrastim (Neupogen, Amgen) following the approval of filgrastim-sndz (Zarxio, Sandoz) in 2015.

Read the Pfizer corporate press release here.

Posted 7/23/2018

FDA Approves Ribociclib in Combination for Advanced, Metastatic Breast Cancer
On July 18, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corp.) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.

The FDA also approved ribociclib in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

Read the full FDA press release here.

Posted 7/18/18

FDA Approves Enzalutamide for Castration-resistant Prostate Cancer

On July 13, 2018, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC).

This approval broadens the indicated patient population to include patients with both non-metastatic CRPC (NM-CRPC) and metastatic CRPC. Enzalutamide was previously approved for the treatment of patients with metastatic CRPC.

Read FDA announcement.

Posted 7/16/2018

CMS Posts MIPS Final Scores, Performance Feedback for Review

On July 2, 2018, CMS announced that participants in the Merit-based Incentive Payment System (MIPS) in 2017 could review their MIPS final score and performance feedback on the Quality Payment Program website. The payment adjustment received in 2019 is based on this final score. A positive, negative, or neutral payment adjustment will be applied to the Medicare paid amount for covered professional services furnished under the Medicare Physician Fee Schedule in 2019.

MIPS eligible clinicians or groups (along with their designated support staff or authorized third-party intermediary), including those who are subject to the APM scoring standard, may request for CMS to review their performance feedback and final score through a process called targeted review.

If you believe an error has been made in your MIPS payment adjustment calculation, you can request a targeted review until September 30, 2018. The following are examples of circumstances in which you may wish to request a targeted review:
- Errors or data quality issues on the measures and activities you submitted
- Eligibility issues (e.g., you fall below the low-volume threshold and should not have received a payment adjustment)
- Being erroneously excluded from the APM participation list and not being scored under APM scoring standard
- Not being automatically reweighted even though you qualify for automatic reweighting due to the 2017 extreme and uncontrollable circumstances policy
You can access your MIPS final score and performance feedback and request a targeted review by:
- Going to the Quality Payment Program website
- Logging in using your Enterprise Identity Management (EIDM) credentials; these are the same EIDM credentials that allowed you to submit your MIPS data. Please refer to the EIDM User Guide for additional details.
CMS has posted new resources on CMS.gov to help eligible clinicians and groups understand their Merit-based Incentive Payment System (MIPS) final score, performance feedback, and payment adjustment, as well as the targeted review process. The new resources include:
- MIPS Performance Feedback Fact Sheet: Offers an overview of what performance feedback is, who receives the feedback, and how to access it on the Quality Payment Program website.
- Targeted Review of the 2019 MIPS Payment Adjustment Fact Sheet: Details what a targeted review is and when and how to request a targeted review.
- Targeted Review of the 2019 MIPS Payment Adjustment User Guide: Provides an overview of the targeted review process, and how to access and complete the targeted review request form.
For more information, visit the Quality Payment Program Resource Library on CMS.gov to review new and existing Quality Payment Program resources, or contact the Quality Payment Program at QPP@cms.hhs.gov or 1-866-288-8292 (TTY: 1-877-715-6222).
Posted 7/2/2018

FDA Approves Encorafenib/Binimetinib Combo for Advanced Melanoma with BRAF Mutation
On June 27, 2018, the U.S. Food and Drug Administration (FDA) approved encorafenib and binimetinib (Braftovi and Mektovi, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

Read FDA announcement.

Posted June 27, 2018

FDA Restricts Use of Keytruda and Tecentriq for Urothelial Cancer
On June 20, 2018, the FDA announced that it was restricting the use of Keytruda (pembrolizumab) and Tecentriq (atezolizumab) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy.

This restriction results from decreased survival associated with the use of Keytruda or Tecentriq as monotherapy compared to platinum-based chemotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).

Read the full FDA announcement here.

Posted 6/21/2018

...31 32 33

Industry News

FDA Expands Approval of HPV Vaccine to People Aged 27 to 45

FDA Approves Dacomitinib for Metastatic NSCLC

FDA Approves Ibrutinib Plus Rituximab for Rare Blood Cancer

FDA Approves Pembrolizumab + Chemotherapy for NSqNSCLC

FDA Approves Filgrastim Biosimilar for AML

FDA Approves Ribociclib in Combination for Advanced, Metastatic Breast Cancer

FDA Approves Enzalutamide for Castration-resistant Prostate Cancer

CMS Posts MIPS Final Scores, Performance Feedback for Review

FDA Approves Encorafenib/Binimetinib Combo for Advanced Melanoma with BRAF Mutation

FDA Restricts Use of Keytruda and Tecentriq for Urothelial Cancer