Industry News

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

Pfizer’s Biosimilar Retacrit® Receives Q-Codes

On May 15, 2018 the U.S. Food and Drug Administration approved Retacrit (epoetin alfa-epbx), a biosimilar to Epogen^®/Procrit^® (epoetin alfa). Retacrit is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) in the United States and is approved for the same indications as Epogen/Procrit.

CMS has granted two Q-codes for Retacrit effective July 1, 2018:

Q5105: Injection, epoetin alfa, biosimilar, (Retacrit) (for esrd on dialysis), 100 units

Q5106: Injection, epoetin alfa, biosimilar, (Retacrit) (for non-esrd use), 1000 units

View Codes on CMS Website

FDA Approves Pembrolizumab for Treatment of PMBCL
On June 13, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy.

Read the FDA press release here.

Posted 6/19/2018

FDA Approves Pembrolizumab for Advanced Cervical Cancer
On June 12, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck and Co. Inc.) for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Read the full FDA press release here.

Posted 6/13/2018

FDA Approves Venetoclax for CLL, Small Lymphocytic Lymphoma

On June 8, 2018, the Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

Read the full FDA announcement here.

Posted 6/11/2018

Pfizer’s Biosimilar RETACRIT® (epoetin alfa-epbx) Approved by U.S. FDA
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FDA approves ADCETRIS® plus chemotherapy for first-line treatment of cHL
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CMS Begins Mailing Out New Medicare Cards

The Centers for Medicare & Medicaid Services (CMS) has begun mailing its newly-designed Medicare cards with new Medicare Beneficiary Identifiers to newly eligible and current Medicare beneficiaries. Cards will be sent out on a rolling basis throughout 2018 to fulfill the CMS requirement to remove Social Security Numbers from all Medicare cards by April 2019.

CMS will host a special Open Door Forum on April 5, 12:30 – 1:30 PM EST, to share updates about the new Medicare card mailing, information on how people with Medicare can look up their new Medicare card number or print a replacement card, and updates on resources for partners. To participate, visit https://webinar.cms.hhs.gov/r51uia09fgq/ and use the following information:
- Dial-In Number: 1-800-837-1935
- Conference ID #: 7065199
Check cms.gov/newcard often for the most up-to-date information.

Posted 4/4/2018

IMBRUVICA® Approved in New Formulation as One Pill, Once Daily
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