Novartis AG NVS announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the approval of breast cancer drug, Piqray (alpelisib).
The committee has recommended the approval of the drug in combination with AstraZeneca’s AZN Faslodex for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.
The positive CHMP opinion was based on the results of the phase III SOLAR-1 study, which demonstrated that Piqray plus Faslodex nearly doubled median progression-free survival (PFS) compared to Faslodex alone in these patients. PFS subgroup analyses demonstrated consistent efficacy in favor of Piqray, irrespective of the presence or absence of lung/liver metastases.
The European Commission will review the CHMP recommendation and a decision is expected in approximately two months.
The drug is already approved in the United States and a tentative approval in Europe should boost sales.
The market potential for Piqray is good as PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer and approximately 40% of patients living with HR+/HER2- breast cancer have this mutation.
However, competition is stiff in this space from the likes of Roche RHHBY.
The stock has lost 8% in the year so far compared with the industry’s decline of 0.5%.
Separately, Novartis announced updated results from the COMBI-AD study. The results showed that treatment with Tafinlar (dabrafenib) and Mekinist (trametinib) following the surgical removal of melanoma offers a long-term and durable relapse-free survival (RFS) benefit to high-risk patients diagnosed with stage III, BRAF-mutation positive melanoma. Moreover, 52% of patients treated with adjuvant Tafinlar + Mekinist were alive and relapse-free at five years. Data from the five-year follow-up of the COMBI-AD trial were presented at the ASCO20 Virtual Scientific Program.
Meanwhile, AveXis, a Novartis company, collaborated with Massachusetts Eye and Ear and Massachusetts General Hospital, members of Mass General Brigham, for the production of a vaccine for COVID-19. AveXis is contributing its technology, expertise and supply chain to supply the AAV vaccine for COVID clinical studies scheduled to begin in the second half of 2020. AveXis will lead the manufacturing efforts of the new vaccine, utilizing its AAV technology for the treatment of rare and life-threatening neurological genetic diseases.
Given the widespread pandemic, quite a few pharma bigwigs have jumped into this race of coming up with a possible treatment or vaccine for COVID-19. Merck MRK recently announced a deal to acquire Austrian private biotech, Themis, which has a COVID-19 vaccine candidate in preclinical development. Merck has also entered into a collaboration agreement with biotech company, Ridgeback Biotherapeutics LP, to develop EIDD-2801, an orally available antiviral candidate currently in early clinical development for the treatment of patients with COVID-19. The company has also signed a collaboration agreement with a non-profit research organization, IAVI, to co-develop a vaccine to prevent COVID-19.
Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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