FDA approved Pemazyre (pemigatinib), a selective fibroblast growth factor receptor inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement.
FDA approved Imbruvica (ibrutinib) for pediatric patients 1 year of age or older with chronic graft versus host disease after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension.
On August 5, 2022, FDA approved Nubeqa (darolutamide) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).
Tabrecta (capmatinib) was granted regular approval for adult patients with metastatic NSCLC whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test.
FDA has approved Imfinzi (durvalumab), in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer.
AstraZeneca’s tablet formulation of Calquence (acalabrutinib) has been approved in the US for all current indications, including adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma and for patients with relapsed or refractory mantle cell lymphoma, which is approved under accelerated approval based on overall response rate.
The European Commission has approved Scemblix (asciminib) for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors.
FDA accepted the supplemental Biologics License Application for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma.
BrainSpec, the web-based software platform that intends to use existing MRI machines to enable virtual biopsies of the brain, has received FDA designation as a breakthrough device for estimating isocitrate dehydrogenase (IDH) status in glioma patients in whom biopsy is inadvisable.
FDA issued a revised draft guidance for industry, “Charging for Investigational Drugs Under an IND: Questions and Answers,” which responds to frequently asked questions about FDA’s processes, policies, and regulation regarding charging patients for investigational new drugs under certain circumstances in clinical trials or expanded access for treatment use.
