Pfizer Inc. announced it has received a Complete Response Letter from FDA in response to the Biologics License Application for the company's proposed trastuzumab biosimilar. In the CRL, FDA highlighted the need for additional technical information.
FDA has approved Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
FDA has granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.
FDA approved Tavalisse (fostamatinib disodium hexahydrate tablets) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
FDA has issued a draft guidance, “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination,” to describe for sponsors of certain oncology trials an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic in a trial of investigational cancer drug or biological products is considered significant risk, non-significant risk, or exempt from further pre-market review.
FDA approved rucaparib (Rubraca), a poly ADP-ribose polymerase inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
FDA has finalized two guidances to drive the efficient development of a novel technology that scans a person's DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments. The guidances provide recommendations for designing, developing, and validating tests that use the technology, called next generation sequencing.
Karyopharm Therapeutics Inc. received the FDA Fast Track designation for an oral Selective Inhibitor of Nuclear Export compound selinexor for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy.
Nanobiotix and MD Anderson Cancer Center said they will collaborate on preclinical research involving NBTXR3, Nanobiotix's lead product.
European Commission has approved an expanded indication for XGEVA (denosumab) for the prevention of skeletal-related events in adults with advanced malignancies involving bone.
