Roche, Bristol-Myers Squibb, and Amgen Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Roche, Bristol-Myers Squibb, and Amgen.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, December 20, 2017 to Tuesday, January 9, 2017.

FDA OKs New Use for Roche’s Breast Cancer Drug Perjeta
The US Food and Drug Administration (FDA) has approved Roche’s Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early-stage breast cancer at high risk of recurrence.

The FDA has also converted the previously granted accelerated approval of the Perjeta-based regimen to full approval for neoadjuvant (before surgery) treatment of HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (either greater than two centimeters in diameter or node-positive). People receiving the neoadjuvant Perjeta-based regimen should continue Perjeta and Herceptin after surgery to complete one year of treatment.

Perjeta in combination with Herceptin and docetaxel chemotherapy is also approved in the US and the European Union for people with previously untreated HER2-positive metastatic breast cancer.

Source: Roche

FDA OKs New Use of BMS’ Cancer Drug Opdivo
The US Food and Drug Administration (FDA) has approved a new indication for Bristol-Myers Squibb’s Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Opdivo received breakthrough therapy designation from the FDA for the adjuvant treatment of patients with high-risk, fully resected melanoma in September 2017.

In the US, Opdivo is indicated for treating BRAF V600 mutation-positive unresectable or metastatic melanoma and BRAF V600 wild-type unresectable or metastatic melanoma as a single agent; unresectable or metastatic melanoma in combination with Yervoy (ipilimumab); metastatic non-small cell lung cancer; advanced renal cell carcinoma; classical Hodgkin lymphoma; recurrent or metastatic squamous cell carcinoma of the head and neck; and locally advanced or metastatic urothelial carcinoma.

Source: Bristol-Myers Squibb

FDA Approves New Use for Amgen’s Cancer Drug Xgeva
The US Food and Drug Administration (FDA) has approved a new use for Amgen’s Xgeva (denosumab) to expand the currently approved indication for preventing skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.

Xgeva is a fully human monoclonal antibody that is designed to bind to and neutralize RANK ligand, a protein used in the formation, function, and survival of osteoclasts that break down bone, thereby inhibiting osteoclast-mediated bone destruction, according to information from Amgen. Amgen says additional regulatory applications for Xgeva for preventing skeletal-related events in patients with multiple myeloma are underway and have been submitted to health authorities worldwide.

Source: Amgen

FDA OKs Pfizer’s, Merck & Co.’s New Diabetes Drug and Combo Therapy
The US Food and Drug Administration (FDA) has approved Merck & Co.’s and Pfizer’s Steglatro (ertugliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the fixed-dose combination drug, Steglujan (ertugliflozin and sitagliptin).

In addition to ertugliflozin, the active pharmaceutical ingredient (API) co-developed by the companies, the combination drug Steglujan includes the API from Merck & Co.’s Januvia (sitagliptin), a diabetes drug with 2016 sales of $5.44 billion.

In 2013, Merck & Co. and Pfizer entered into a worldwide collaboration, except Japan, for the co-development and co-promotion of ertugliflozin. The Merck & Co. sales force will exclusively promote Steglatro and the two fixed-dose combination products in the US. Merck & Co. and Pfizer plan to share potential revenues and certain costs on a 60%/40% basis, respectively, and Pfizer may be entitled to additional milestone payments.

Steglatro (ertugliflozin) and Steglujan (ertugliflozin and sitagliptin) are expected to be available in pharmacies in January 2018. Segluromet (ertugliflozin and metformin hydrochloride) is expected to be available in February 2018.

Source: Pfizer

FDA OKs New Use for Pfizer’s Leukemia Drug Bosulif
The US Food and Drug Administration (FDA) has approved Pfizer’s supplemental new drug application (sNDA) to expand the indication for Bosulif (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).

Bosulif is an oral, once-daily, tyrosine kinase inhibitor, which inhibits the Bcr-Abl kinase that promotes CML; it is also an inhibitor of Src-family kinases.

The sNDA was reviewed and approved under the FDA’s priority review and accelerated approval programs based on molecular and cytogenetic response rates. Continued approval for this indication may be contingent upon verification and confirmation of clinical benefit in an ongoing long-term follow up trial. Bosulif was first approved in September 2012 in the US for treating adult patients with chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.

Pfizer and Avillion, a London, UK-based company focused on increasing research and development output, entered into an exclusive collaborative development agreement in 2014 to conduct the trial for Bosulif. Under the agreement, Avillion provided funding and conducted the trial to generate the clinical data used to support this application and other potential regulatory filings for marketing authorization for Bosulif as first-line treatment for patients with chronic phase Ph+ CML. With this approval, Avillion is eligible to receive milestone payments from Pfizer. Pfizer retains all rights to commercialize the drug globally.

Source: Pfizer

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