Oncologists may soon have another weapon at their disposal in the fight against advanced follicular lymphoma, a type of cancer in need of new treatment options. The Food and Drug Administration has accepted Epizyme's (NASDAQ: EPZM) application to review tazemetostat for use by patients with that form of cancer.

It's a new year, which means it's a new opportunity for drugmakers hoping to pass FDA muster for new therapies––some of which could be sniffing after blockbuster sales.

In the first quarter, the FDA is set to decide on a group of new drugs that come with high hopes, high scrutiny and, in some cases, raised eyebrows from the agency staff who have reviewed them.

Epizyme will have to overcome a tough assessment from the FDA’s in-house review team for their cancer drug tazemetostat if they expect to make it to the market with an OK on epithelioid sarcoma. But they $EPZM may well have the agency’s oncology panel on their side, where there’s a built-in bias in favor of even marginal new drugs when it comes to offering physicians and patients another drug to choose from.

Biotech stocks were seen consolidating last week after advancing in the previous week. The iShares NASDAQ Biotechnology Index (NASDAQ: IBB) reached a 52-week high of 121.16 Monday, although it has come off this level since then.

The week saw huge moves in reaction to presentations at the American Society of Hematology annual meeting. A few M&A announcements were made, including Merck & Co., Inc.'s (NYSE: MRK) deal to buy ArQule, Inc. (NASDAQ: ARQL) and Sanofi SA's (NASDAQ: SNY) proposed purchase of Synthorx Inc (NASDAQ: THOR).

Epizyme announced that the US Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for accelerated approval of tazemetostat, its lead investigational agent.

Epizyme has posted updated data from the phase 2 trial it hopes will secure tazemetostat approval in epithelioid sarcoma. The data feature a slight uptick in objective responses offset by rises in the rates of some adverse events.

Epizyme has taken another step forward on the path to its first commercialized drug, announcing Thursday submission of an application to the Food and Drug Administration for accelerated approval of its most advanced experimental cancer drug.

Epizyme is reporting that the FDA has lifted the partial hold it imposed on their clinical trial work for the lead drug tazemetostat, but it has some work yet to do before it gets all the studies back on track.

Despite an FDA hold on its lead program, tazemetostat, Epizyme is trucking along, reporting interim data for a phase 2 trial in follicular lymphoma, working to resolve the hold and looking to file an NDA for a solid tumor indication later this year.

Epizyme (NASDAQ: EPZM) said Monday that a pediatric patient taking its experimental cancer drug tazemetostat developed a new cancer, different than the one tazemetostat had been treating. The secondary cancer, a lymphoma, spurred the Food and Drug Administration to halt all new enrollment in tazemetostat trials.