This week, the FDA granted approval to Pfizer’s (PFE - Free Report) Daurismo, the drug giant’s fourth new cancer drug in less than three months. It also approved the label expansion of AbbVie (ABBV - Free Report) /Roche’s drug Venclexta. Both the drugs gained approval for the treatment of acute myeloid leukemia (AML), a rare blood cancer in newly diagnosed patients. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave positive recommendations for granting marketing approval to several drugs this week.
Recap of the Week’s Most Important Stories
Pfizer Gets FDA Nod for Rare Cancer Medicine: The FDA granted approval to Daurismo for a rare blood cancer, Pfizer’s fourth cancer medicine in less than three months. Daurismo (glasdegib), a once-daily oral medicine is approved for use in combination with low-dose cytarabine (LDAC) — a kind of chemotherapy treatment — for the treatment of newly-diagnosed acute myeloid leukemia (AML) in patients 75 years or older or who cannot take intensive chemotherapy. However, the approval comes with a boxed warning on the U.S. label for embryo-fetal toxicity
Pfizer’s recent new cancer drug approvals include Lorbrena (lorlatinib) for second line non-small-cell lung cancer, Vizimpro (dacomitinib) for advanced NSCLC with EGFR activating mutations and Talzenna (talazoparib), an orally-available PARP inhibitor for advanced breast cancer.
However, Pfizer’s late-stage study evaluating its PD-L1 inhibitor Bavencio (avelumab), in patients with platinum-resistant/refractory ovarian cancer, failed to meet the primary endpoints of overall survival (OS) or progression-free survival (PFS).In the study, both PFS and OS did not reach statistical significance. Bavencio is marketed for metastatic Merkel cell carcinoma in the United States, Europe and Japan and for the second-line treatment of locally advanced or metastatic urothelial carcinoma in the United States.
Pfizer was also in news this week as a Wall Street report stated that it plans to increase the list prices of 41 prescription drugs in 2019. The drug giant had put off such increases earlier this year as it faced criticism from President Trump.
AbbVie/Roche Get FDA Nod for Venclexta in First-Line AML: FDA also granted accelerated approval to AbbVie and partner Roche’s supplemental new drug application (sNDA) looking for a label expansion of Venclexta (venetoclax) for the first-line treatment of acute myeloid leukemia (AML), one of the most aggressive blood cancers.
Venclexta can now be prescribed in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) in AML patients who are ineligible for intensive chemotherapy. Venclexta is now approved for two different blood cancers in the United States - newly-diagnosed AML and relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)
CHMP Gives Positive Opinion to Several Drugs: The CHMP gave a positive opinion, recommending approval of J&J’s (JNJ - Free Report) Erleada (apalutamide) for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. Erleada gained FDA approval in the United States in February. The CHMP also gave a nod to Glaxo’s (GSK - Free Report) filing looking for EU approval of its HIV drug, Tivicay as a two-drug regimen (2DR) in combination with lamivudine.
The regulatory submission for the update to the Tivicay EU label is based on data from phase III GEMINI 1 & 2 studies. Sanofi (SNY - Free Report) also gained positive CHMP opinion for fexinidazole, an oral treatment for human African trypanosomiasis (HAT) or sleeping sickness. Novartis’ (NVS - Free Report) filing looking for label expansion of its CDK4/6 inhibitor, Kisqali in combination with fulvestrant, as a first or second-line treatment for HR+/HER2- locally advanced or metastatic breast cancer, also received CHMP nod. The final decision by the European Union on these products is expected in the coming months.
AstraZeneca Presents Final OS Data From MYSTIC Study: AstraZeneca (AZN - Free Report) announced final overall survival data from the pivotal phase III MYSTIC study, evaluating Imfinzi in first-line lung cancer. The MYSTIC study evaluated Imfinzi, both as a monotherapy and in combination with tremelimumab, in treatment-naïve non-small cell lung cancer (NSCLC) patients whose tumors express PD-L1 on 25% or more of their cancer cells.The data from the primary analysis population of patients showed that Imfinzi monotherapy as well as in combination with tremelimumab failed to achieve statistical significance in the primary endpoint of overall survival compared to standard-of-care platinum-based chemotherapy. Per data announced in July last year, the study failed to show improvement in progression-free survival, thereby failing to meet the first primary endpoint.
Novartis Gets FDA Nod for Promacta in First-Line Setting: Novartis gained FDA approval for label expansion of its anemia drug, Promacta as a first-line treatment option for severe aplastic anemia (SAA) in combination with standard immunosuppressive therapy (IST). Promacta is already marketed for SAA for patients who have had an insufficient response to IST. A decision by the European Medicines Agency for a similar label expansion is expected in 2019. Promacta was also granted a Breakthrough Therapy designation by the FDA as a counter measure for hematopoietic sub-syndrome of acute radiation syndrome (H-ARS).
Glaxo Files for Approval of Nucala in Pediatric Patients: Glaxo filed a supplemental Biologics License Application (sBLA) to the FDA, seeking label expansion of its severe eosinophilic asthma drug, Nucala, in pediatric patients(aged six to 11 years) in the United States. The drug is already marketed in the United States and EU for patients aged 12 years or older. In the EU, it received approval for pediatric use (from aged six-17 years) in severe eosinophilic asthma in August. Nucala is a key drug in Galxo’s respiratory portfolio, recording sales growth of 81% at constant exchange rate in the first nine months of 2018.
FDA Accepts Allergan’s sNDA for Avycaz: The FDA accepted Allergan’s sNDA looking for approval of the latter’s antibacterial medicine, Avycaz, for the pediatric patient population. The sNDA is seeking approval for Avycaz for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI - in combination with metronidazole) in pediatric patients, aged three months and above. Avycaz is already approved to treat these infections in adult patients.
The NYSE ARCA Pharmaceutical Index declined 0.9% in the last four trading sessions.
Here is how the seven major stocks performed in the last four trading sessions:
None of the stocks recorded any significant increase. Glaxo recorded the highest gain (0.3%) while AstraZeneca declined the most (2.8%) in the last four trading sessions.
In the past six months, Lilly has been the biggest gainer (35.7%) while Glaxo recorded the lowest gain (1.2%).
(See the last pharma stock roundup here: FDA Updates on MRK, AZN’s Cancer Drugs, Bayer’s Q3 Earnings)
What's Next in the Pharma World?
Watch out for pipeline and regulatory updates next week.
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