The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended three cancer drugs for approval at its September meeting.
The CHMP recommended granting a marketing authorization for palbociclib (Ibrance, Pfizer) for the treatment of locally advanced or metastatic breast cancer. Palbociclib is specifically for hormone receptor (HR)–positive and human epidermal growth factor receptor 2 (HER2)–negative disease.
Palbociclib acts as an inhibitor of cyclin-dependent kinases 4 and 6, which are involved in promoting the growth of cancer cells.
In postmenopausal women, palbociclib is used in combination with an aromatase inhibitor or with fulvestrant (Faslodex, Novartis) in cases in which the patient has undergone prior hormone therapy. For premenopausal women, the hormone therapy should be combined with a luteinizing hormone-releasing hormone.
The recommendation is based on two main phase 3 studies.
PALOMA-2 compared treatment with palbociclib and letrozole (Femara, Novartis), an aromatase inhibitor, with letrozole alone. Median progression-free survival for the palbociclib treatment group (n = 444) was 24.8 months compared to 14.5 months for the letrozole-alone group (n = 222).
PALOMA-3 compared treatment with palbociclib and fulvestrant with fulvestrant alone among women of any menopausal status. Median progression-free survival for the palbociclib treatment group (n = 347) was 11.2 months compared to 4.6 months for the fulvestrant-alone group (n = 174).
The most frequently reported adverse events with palbociclib are associated with myelosuppression, according to the European Medicines Agency. Other side effects include infections, fatigue, nausea and vomiting, inflammation of stomatitis, diarrhea, and alopecia.
Palbociclib was approved in the United States in 2015 in combination with letrozole for HR-positive and HER2-negative breast cancer in the first-line treatment and in 2016 in combination with fulvestrant for second-line treatment of the same type of breast cancer.
Soft Tissue Sarcoma and Multiple Myeloma Drugs
The CHMP also recommended a conditional marketing authorization for olaratumab (Lartruvo, Eli Lilly) for the treatment of adults with advanced soft tissue sarcoma not amenable to curative treatment with radiotherapy or surgery and who have not been previously treated with doxorubicin (multiple brands).
The recommendation is based on data from the phase 2 JGDG, an open-label, randomized trial of olaratumab, a selective platelet-derived growth factor–alpha inhibitor.
In the trial, which included 133 patients, median overall survival was longer with the combination of olaratumab plus doxorubicin than with doxorubicin monotherapy (26.5 vs 14.7 months).
Median progression-free survival — the primary endpoint — was 6.6 months with the doxorubicin combination and 4.1 months with doxorubicin monotherapy. The difference met the predefined primary endpoint.
However, the difference in progression-free survival was just 2.5 months, whereas the difference in overall survival was 11.8 months.
This outcome "is as much promising as puzzling," said an expert, Winette van der Graaf, MD, from the sarcoma unit of the Royal Marsden NHS Foundation Trust in London, United Kingdom, earlier this year.
The most common adverse events with olaratumab were nausea, musculoskeletal pain, neutropenia, and mucositis.
As part of the conditional marketing authorization, Eli Lilly must provide results from the ongoing phase 3 ANNOUNCE trial to confirm the earlier results.
Olaratumab was reviewed under EMA's accelerated assessment mechanism and has an orphan designation.
Finally, the CHMP recommended granting a conditional marketing authorization for ixazomib (Ninlaro, Takeda Pharmaceuticals), an oral proteasome inhibitor, for the treatment of multiple myeloma.
This follows a reexamination of their earlier negative opinion, announced in May of this year, which cited insufficient evidence of benefit.
A European investigator endorsed the drug in a company press statement earlier this year.
"In Europe, where no oral proteasome inhibitor is available, ixazomib would fill a noticeable void and enable the first all-oral triplet combination therapy for patients with relapsed or refractory multiple myeloma," said Philippe Moreau, MD, from the University of Nantes in France.
Last year, the US Food and Drug Administration approved ixazomib for the treatment of multiple myeloma in patients who have received one or more previous therapies. The drug was approved as part of a triplet therapy — in combination with lenalidomide (Revlimid, Celgene) and the corticosteroid dexamethasone.
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