Industry News

Udenyca Well Prepared to Meet Market Demand
Coherus BioSciences, Inc., has announced that its United States manufacturing and distribution is well positioned to
ensure uninterrupted availability of Udenyca^® (pegfilgrastim-cbqv) for patients. Coherus does not source active pharmaceutical ingredients for Udenyca^® from China, or India, and its manufacturing site in Boulder, Colorado has not been impacted by coronavirus, the company said in a statement.

Read the company statement.

Posted 3/11/2020

FDA Approves Sarclisa® for Relapsed Refractory Multiple Myeloma

On March, 2, 2020, the U.S. Food and Drug Administration (FDA) approved Sarclisa^® (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is expected to be available to patients in the U.S. shortly.

Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells.

Sarclisa has Orphan Drug Designation status from the FDA.

Read corporate press release.

Posted 3/2/2020

CMS Issues Proposed Changes to Medicare Advantage & Part D

On Feb. 5, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule and Advance Notice Part II.

The CY 2021/2022 Medicare Advantage and Part D Proposed Rule (CMS- 4190-P) would:
- require Part D plans to offer real-time drug price comparison tools to beneficiaries starting Jan. 1, 2022, to allow consumers to shop for lower-cost alternative therapies under their prescription drug benefit plan.
- allow a second, “preferred” specialty tier in Part D with a lower cost sharing amount.
- require Part D plans to disclose the measures they use to evaluate pharmacy performance in their network agreements. This would allow CMS to track and report publicly how plans are measuring and applying pharmacy performance measures.
In the Advance Notice, the agency asks for comments on potentially developing measures of generic and biosimilar utilization in Medicare Part D as part of a plan’s star rating.

Access a fact sheet on the CY 2021/2022 Medicare Advantage and Part D Proposed Rule (CMS- 4190-P).
Download the proposed rule.

Access a fact sheet on the 2021 Medicare Advantage and Part D Advance Notice Part II.
Download Medicare Advantage and Part D Advance Notice Part II.

Posted 2/6/2020

FDA Approves Avapritinib for GIST Subset
On Jan. 9, 2020, the U.S. Food and Drug Administration (FDA) announced approval of avapritinib (Ayvakit) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) – harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. This approval includes GIST that harbors a PDGFRA D842V mutation, which is the most common exon 18 mutation. Ayvakit is a kinase inhibitor, meaning it blocks a type of enzyme called a kinase and helps keep the cancer cells from growing.

Read the FDA approval announcement.

Posted 1/9/2020.

ACS Report Finds Largest One-Year Drop in Cancer Deaths

The American Cancer Society’s annual report on U.S. cancer statistics, released Jan. 8, announced the greatest one-year decline in deaths from cancer since 1930. From 2016 to 2017, overall deaths from cancer dropped 2.2 percent. Between 1991 and 2017, the U.S. has seen the overall cancer death rate drop 29 percent.

In a statement, lead study author Rebecca Siegel, MPH, attributed the record drop to improved statistics related to lung cancer. While a decrease in smoking rates has contributed to the decline, Siegel also credited recent advances in lung cancer treatment for this year's record drop. These include surgical advances, improved diagnostic screening, as well as advances in radiation therapy and anticancer therapeutics.

The U.S. continues to see increases in new cases of certain cancers including cancers of the kidney, pancreas, liver, and oral cavity and pharynx (among non-Hispanic whites), and melanoma skin cancer.
The American Cancer Society estimates for 2019, the U.S. saw approximately 1,762,450 cancers diagnosed.

Read the full report.
Read Facts & Figures 2020.

Posted 1/9/2019

FDA Approves Pembrolizumab for Treatment of Subset of Bladder Cancer Patients
On Jan. 8, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Read the FDA announcement.

Posted 1/8/2020

FDA Approves Olaparib for Pancreatic Cancer
On Dec. 30, 2019, AstraZeneca and Merck announced U.S. Food and Drug Administration (FDA) approval of olaparib (Lynparza) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Patients will be selected for therapy based on an FDA-approved companion diagnostic for Lynparza.

Read the corporate press release.

Myriad Genetics, Inc., announced Dec. 30, 2019, FDA has approved the company's BRACAnalysis CDx® for use as a companion diagnostic test by healthcare professionals to identify patients with metastatic pancreatic cancer who have a germline BRCA mutation and are candidates for treatment with PARP inhibitor Lynparza® (olaparib).

Read the corporate press release.

Posted 12/30/2019

FDA Approves Enhertu for Previously Treated Unresectable or Metastatic HER2+ Breast Cancer
On December 20, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu^®, Daiichi Sankyo) for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

Read FDA announcement.

Posted 12/20/2019

FDA Approves Padcev (enfortumab vedotin-ejfv) for Advanced Urothelial Cancer
On Dec. 18, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in this case, the cell adhesion molecule Nectin-4, which is highly expressed in urothelial cancers.

Padcev is indicated for the treatment of locally advanced or metastatic urothelial cancer in adults who have previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy. Platinum-containing chemotherapy, PD-1 and PD-L1 inhibitors are standard treatments for patients with bladder cancer, the sixth most common cancer in the U.S. Urothelial cancer, which accounts for more than 90% of bladder cancers, begins in cells that line the bladder and nearby organs. Padcev is a new type of therapy for patients with advanced urothelial cancer whose disease has progressed on chemotherapy and immunotherapy.

Read FDA announcement.

Posted 12/19/2019

Trump Administration Issues Proposed Rule on Importation of Prescription Drugs
On Dec. 18, 2019, President Trump, along with the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA), issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow states to import certain prescription drugs from Canada. In addition, the administration announced a new draft guidance for industry that allows drug manufacturers to important their own prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.

The proposed rule applies to drugs that meet FDA labeling standards and impose no risk to health and safety. The import rule excludes controlled substances, biological products and intravenous drugs. (FDA's Safe Importation Action Plan.)

Comments on the NPRM are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance are being accepted for 60 days after publication in the Federal Register.

Read the HHS press release.
Read Importation of Prescription Drugs Proposed Rule.
Read new draft guidance for industry.

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Industry News

Udenyca Well Prepared to Meet Market Demand

FDA Approves Sarclisa® for Relapsed Refractory Multiple Myeloma

CMS Issues Proposed Changes to Medicare Advantage & Part D

FDA Approves Avapritinib for GIST Subset

ACS Report Finds Largest One-Year Drop in Cancer Deaths

FDA Approves Pembrolizumab for Treatment of Subset of Bladder Cancer Patients

FDA Approves Olaparib for Pancreatic Cancer

FDA Approves Enhertu for Previously Treated Unresectable or Metastatic HER2+ Breast Cancer

FDA Approves Padcev (enfortumab vedotin-ejfv) for Advanced Urothelial Cancer

Trump Administration Issues Proposed Rule on Importation of Prescription Drugs