Date: 2017-09-14
Type of information: Granting of a Market Authorisation in the US
Product name: Aliqopa® - BAY 80-6946 - copanlisib
Compound: copanlisib
Therapeutic area: Rare diseases - Cancer - Oncology
Action mechanism:
- Kinase inhibitor. Copanlisib is a novel intravenous phosphatidylinositol-3-kinase (PI3K) inhibitor with inhibitory activity predominantly against the PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells.
Company: Bayer Healthcare (Germany)
Disease: follicular lymphoma
Latest news:
- • On September 14, 2017, the FDA has granted accelerated approval to Aliqopa® (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.
- Aliqopa® received an Accelerated Approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. Further clinical trials are required to confirm Aliqopa®’s clinical benefit and the sponsor is currently conducting these studies. The approval of Aliqopa® was based on data from a single-arm trial (Phase II CHRONOS-1 study - NCT01660451) that included 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least two prior treatments. The trial measured how many patients experienced complete or partial shrinkage of their tumors after treatment (overall response rate). In the trial, 59 percent of patients had a complete or partial response for a median 12.2 months.
- Common side effects of Aliqopa® include high blood sugar levels (hyperglycemia), diarrhea, decreased general strength and energy, high blood pressure (hypertension), low levels of certain white blood cells (leukopenia, neutropenia), nausea, lower respiratory tract infections, and low levels of blood platelets (thrombocytopenia).
- Serious adverse reactions were reported in 44 (26%) patients. The most frequent serious adverse reactions that occurred were pneumonia (8%), pneumonitis (5%), and hyperglycemia (5%). Adverse reactions resulted in dose reduction in 36 (21%) and discontinuation in 27 (16%) patients. The most frequently observed adverse drug reactions (?20%) in copanlisib-treated patients were: hyperglycemia (54%), leukopenia (36%), diarrhea (36%), decreased general strength and energy (36%), hypertension (35%), neutropenia (32%), nausea (26%), thrombocytopenia (22%), and lower respiratory tract infections (21%). The safety data reflect exposure to copanlisib in 168 adults with follicular lymphoma and other hematologic malignancies treated with copanlisb 60 mg or 0.8 mg/kg equivalent in clinical trials.
- Women who are pregnant or breastfeeding should not take Aliqopa® because it may cause harm to a developing fetus or newborn baby.
- Aliqopa® was granted Priority Review designation, under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
- Developed by Bayer, copanlisib is the only and first approved PI3K inhibitor with inhibitory activity predominantly against PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells. It is also the only one to be administered intravenously on an intermittent schedule. C
- • On February 5, 2015, the FDA has granted orphan drug designation for copanlisib for the treatment of follicular lymphoma.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-09-14
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2015-02-05
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
