News and Trends March 2019

MARCH 30, 2019
FDA Approves Subcutaneous Herceptin Combo Therapy for Patients With Breast Cancer
by Jennifer Barrett

FDA officials have approved trastuzumab (Herceptin) subcutaneous (SC) injection for certain patients with HER2-positive early and metastatic breast cancer, according to a statement. The approval is based on data from 3 clinical trials in HER2-positive early breast cancer: HannaH, SafeHER, and PrefHER.

The trastuzumab and hyaluronidase-oysk combination is indicated for patients with early disease in combination with chemotherapy, for metastatic disease in combination with paclitaxel, or alone in patients who have received 1 or more chemotherapy regimens.

This SC treatment includes the same monoclonal antibody as intravenous (IV) trastuzumab in combination with recombinant human hyaluronidase PH20, an enzyme that helps deliver trastuzumab under the skin, according to Genentech.

It is a ready-to-use formulation that can be administered in 2 to 5 minutes.

In the HannaH study, neoadjuvant and adjuvant SC trastuzumab and hyaluronidase-oysk treatments were compared with IV trastuzumab, both in combination with chemotherapy. Patients administered SC trastuzumab and hyaluronidase-oysk demonstrated noninferior levels of trastuzumab in the blood and noninferior clinical
efficacy compared with IV trastuzumab.

The SafeHER study evaluated adjuvant trastuzumab and hyaluronidase-oysk and found no new safety signals, according to the data.

Reference
1. FDA approves Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers [news release]. South San Francisco, California; February 28, 2019: Genentech. gene.com/media/press-releases/14779/2019-02-28/fda-approves-herceptin-hylecta-for-subcu. Accessed February 28, 2019.


FDA Accepts sNDA for AML Therapy
by Jennifer Nessel

The fda has accepted a supplemental new drug application (sNDA) for ivosidenib (Tibsovo, Agios Pharmaceuticals) for patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation who are not eligible for standard therapy.1 Ivosidenib is a firstin-class, oral, targeted inhibitor of mutant IDH1.

The FDA accepted the ivosidenib sNDA under its Real-Time Oncology Review pilot program, whose goal is to streamline reviews for oncology drugs by allowing the agency access to clinical trial data before a formal submission, according to a statement.

The submission was based on results from patients with untreated AML from the phase 1 dose-escalation and expansion study of ivosidenib in patients with newly diagnosed AML who were ineligible for standard treatment, according to a statement.1

The sNDA was granted priority review and has been given a Prescription Drug User Fee Act action date of June 21, 2019.

References
  1. American Cancer Society. What is acute myeloid leukemia (AML)? cancer.org/cancer/acute-myeloid-leukemia/about/what-is-aml.html. Updated August 21, 2018. Accessed February 21, 2019.
  2. Agios announces FDA acceptance of supplemental new drug application for TIBSOVO® (ivosidenib) for the treatment of patients with newly diagnosed acute myeloid leukemia with an IDH1 mutation not eligible for standard therapy [news release]. Cambridge, Massachusetts;February 20, 2019: GlobeNewswire. globenewswire.com/news-release/2019/02/20/1738209/0/en/Agios-Announces-FDA-Acceptance-of-Supplemental-New-Drug-Application-for-TIBSOVO-ivosidenib-for-the-Treatment-of-Patients-with-Newly-Diagnosed-Acute-Myeloid-Leukemia-with-an-IDH1-Mu.html. Accessed February 21, 2019.


Generic Therapies for Opioid Dependence Hit the Market
by Kristen Coppock

Two generic buprenorphine and naloxone sublingual film products are on the market to treat opioid dependence, following FDA approval and patent litigation.

The therapies, from Mylan and Dr. Reddy’s Laboratories, are generic equivalents of Indivior PLC’s Suboxone sublingual film.1,2 FDA officials approved both generic versions of buprenorphine and naloxone sublingual film in June 2018. They were the first generic versions of Indivior’s product, according to the agency.3

“When coupled with other social, medical, and psychological services, medication-assisted treatments are often the most effective approach for opioid dependence,” FDA Commissioner Scott Gottlieb, MD, said in a statement.3

“Patients addicted to opioids who are eventually treated for that addiction and successfully transition onto medicines like buprenorphine aren’t swapping one addiction for another, as is sometimes unfortunately said,” Gottlieb said. “They’re able to regain control of their lives and end all the destructive outcomes that come with being addicted to opioids.”

Dr. Reddy’s Laboratories’ buprenorphine and naloxone sublingual film product, in doses of 2.0 mg/0.5 mg, 4.0 mg/1.0 mg, 8.0 mg/2.0 mg, and 12.0 mg/3.0 mg, launched following its FDA approval. However, sales and commercialization activities were halted because of a legal challenge related to Indivior’s patent.

According to Dr. Reddy’s Laboratories, its generic product resumed shipping in late February, following a decision in the company’s favor by the US Court of Appeals for the Federal Circuit.1

“We are pleased with the decision of the appellate court in Dr. Reddy’s favor, vacating the preliminary injunction that had prevented Dr. Reddy’s from continuing to market this important drug to the public,” Marc Kikuchi, CEO of North America Generics, said in a statement.1 “Dr. Reddy’s is committed to providing affordable treatment options for opioid use disorder and
addiction. We look forward to helping patients and our communities in the United States who are impacted by
the opioid epidemic.”

Mylan also said it is launching its buprenorphine and naloxone sublingual film product in doses of 8 mg/2 mg and 12 mg/3 mg, following final FDA approval for the treatment’s abbreviated new drug application.

References 
  1. Dr. Reddy's Laboratories announces the re-launch of its buprenorphine and naloxone Sublingual Film after favorable ruling in patent litigation [news release]. Hyderabad, India, and Princeton, New Jersey; February 20, 2019; Dr. Reddy's Laboratories. businesswire.com/news/home/20190220005717/en/Dr.-Reddys-Laboratories-Announces-Re-Launch-Buprenorphine-Naloxone. Accessed February 22, 2019.
  2. Mylan launches generic Suboxone Sublingual Film to treat opioid dependence [news release]. Hertfortshire, England, and Pittsburgh, Pennsylvania; February 22, 2019: Mylan. investor.mylan.com/news-releases/news-release-details/mylan-launches-generic-suboxoner-sublingual-film-treat-opioid. Accessed February 22, 2019.
  3. FDA approves first generic versions of Suboxone Sublingual film, which may increase access to treatment for opioid dependence [news release]. Silver Spring, MD: June 14, 2018; FDA website. www.fda.gov/newsevents/newsroom/pressannouncements/ucm610807.htm. Accessed February 22, 2018.


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